FACTOID # 29: 73.3% of America's gross operating surplus in motion picture and sound recording industries comes from California.
 
 Home   Encyclopedia   Statistics   States A-Z   Flags   Maps   FAQ   About 
 
WHAT'S NEW
 

SEARCH ALL

FACTS & STATISTICS    Advanced view

Search encyclopedia, statistics and forums:

 

 

(* = Graphable)

 

 


Encyclopedia > Food and Drug Administration
FDA logo

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques. FDA can refer to the following: Flag Desecration Amendment Florida Dental Association Food and Drug Administration This is a disambiguation page: a list of articles associated with the same title. ... Image File history File links Food_and_Drug_Administration_logo. ... Image File history File links Food_and_Drug_Administration_logo. ... The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ... A dietary supplement is intended to supply nutrients, (vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a persons diet. ... This article does not cite any references or sources. ... A vaccine is an antigenic preparation used to establish immunity to a disease. ... Biopharmaceuticals are medical drugs (see pharmacology) produced by biotechnology. ... Blood transfusion is the process of transferring blood or blood-based products from one person into the circulatory system of another. ... // COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices defines a ‘medical device’ as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for... This box:      Electromagnetic (EM) radiation is a self-propagating wave in space with electric and magnetic components. ... Make-up redirects here. ... E. Coli bacteria under magnification Sanitation is the hygienic disposal or recycling of waste, as well as the policy and practice of protecting health through hygienic measures. ... Turtles and terapins may mean: plural of turtle Teenage Mutant Ninja Turtles The Turtles band Turtles band Turtles Music stores See also: Turtle (disambiguation) This is a disambiguation page: a list of articles associated with the same title. ... Horse semen being collected for breeding purposes. ...

Contents

Organization

The FDA is an agency within the United States Department of Health and Human Services. The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ...


The agency is currently organized into the following major subdivisions,each focused on a major area of regulatory responsibility:

The Center for Food Safety and Applied Nutrition is the branch of the Food and Drug Administration (FDA) which regulates food, dietary supplements, and cosmetics. ... The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. ... The Center for Biologics Evaluation and Research (CBER) is one of five main centers for the United Statess Food and Drug Administration (US FDA). ... The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. ... The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. ... The National Center for Toxicological Research is the branch of the United States Food and Drug Administration which conducts research to define biological mechanisms of action underlying the toxicity of products regulated by the FDA. Category: ... FDA-OCI logo The Office of Criminal Investigations (OCI) is a relatively small but important part of the U.S. Food and Drug Administration. ... The Office of Regulatory Affairs, or ORA is the part of the FDA [1]that enforces the laws that govern food, drugs and medical devices. ...

Leadership

The FDA is headed by Commissioner Andrew von Eschenbach, who was confirmed by the Senate on December 7, 2006 after serving as Acting Commissioner for fourteen months. Von Eschenbach succeeded Lester Crawford, who resigned on September 23, 2005, just two months after his final Senate confirmation. Andrew C. von Eschenbach (born October 30, 1941 in Philadelphia, Pennsylvania) is the current Commissioner of the United States Food and Drug Administration. ... is the 341st day of the year (342nd in leap years) in the Gregorian calendar. ... Year 2006 (MMVI) was a common year starting on Sunday of the Gregorian calendar. ... Dr. Lester M Crawford Dr. Lester M. Crawford (born 1939) is a former Commissioner of the United States Food and Drug Administration (FDA). ... is the 266th day of the year (267th in leap years) in the Gregorian calendar. ... Year 2005 (MMV) was a common year starting on Saturday (link displays full calendar) of the Gregorian calendar. ...


Authorization and regulatory mandate

Most federal laws administered through the FDA are codified into the Food, Drug and Cosmetic Act, [1] also called Title 21, Chapter 9 of the United States Code (21 USC 9).


The programs for FDA safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety. It regulates other products with a set of published standards enforced with a modest number of facilities inspections.


Funding

Federal budget

The FDA's federal budget request for 2008 totaled $2.1 billion, a $105.8 million increase from what they received in 2007.[2]


Before the 1990s, the FDA was funded solely by appropriations from the federal government. In response to a variety of issues, Congress adopted various laws in the 1990s that imposed a fee on entities that applied for FDA approval of a drug, biologic or medical device. Congress in Joint Session. ...


User fees

FDA is also funded by user fees submitted with New Drug Applications under the Prescription Drug User Fee Act (PDUFA) in which the industry pays a fee for the review of the new product. A similar process is used for medical devices under the Medical Device User Fee and Modernization Act (MDUFMA). These fees may be waived or reduced for small businesses.


Regulatory Programs

Food and dietary supplements

The Center for Food Safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring the safety and accurate labeling of nearly all food products in the United States.[3] One exception is products derived from traditional domesticated animals, such as cattle and chickens, which fall under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service. Products which contain minimal amounts of meat are regulated by FDA, and the exact boundaries are listed in a memorandum of understanding between the two agencies. However, medicines and other products given to all domesticated animals are regulated by FDA through a different branch, the Center for Veterinary Medicine. Other consumables which are not regulated by the FDA include beverages containing more than 7% alcohol (regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives in the Department of Justice), and non-bottled drinking water (regulated by the United States Environmental Protection Agency (EPA)). The Center for Food Safety and Applied Nutrition is the branch of the Food and Drug Administration (FDA) which regulates food, dietary supplements, and cosmetics. ... USDA redirects here. ... The United States Food Safety and Inspection Service is charged with ensuring that all meat, poultry, and processed egg products in the United States are safe to consume and accurately labeled. ... The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. ... The Bureau of Alcohol, Tobacco, Firearms and Explosives (abbreviated ATF, sometimes BATF or BATFE) is a United States federal agency; more specifically a specialized law enforcement and regulatory organization within the United States Department of Justice. ... Robert F. Kennedy Department of Justice Building, Washington, D.C. For animal rights group, see Justice Department (JD) The United States Department of Justice (DOJ) is a Cabinet department in the United States government designed to enforce the law and defend the interests of the United States according to the... EPA redirects here. ...


The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. FDA can take action against dietary supplements only after they are proven to be unsafe. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products. They may not claim to treat, diagnose, cure, or prevent disease and must include a disclaimer on the label.[4] A prescribed dietary supplement supplies nutrients (usually vitamins or minerals) that are missing or not consumed in sufficient quantity in a persons diet. ... A dietary supplement is intended to supply nutrients, (vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a persons diet. ...


Bottled water is regulated in America by the FDA.[5] State governments also regulate bottled water. Tap water is regulated by state and local regulations, as well as the United States EPA. FDA regulations of bottled water generally follow the guidelines established by the EPA, and new EPA rules automatically apply to bottled water if the FDA does not release an explicit new rule.[6] Water bottlers in the US are subject to inspection similar to other food firms, but quality controls for the bottled water industry are not nearly as stringent as those for municipal water supplies.


Drugs

U.S. drug regulation
Prescription drugs
Over-the-counter drugs
This box: view  talk  edit

The Center for Drug Evaluation and Research has different requirements for the three main types of drug products: new prescription drugs, generic drugs and over-the-counter drugs. The most rigorous requirements apply to new prescription drugs. A prescription drug is a medication that is regulated by legislation to require a prescription before it can be obtained. ... Over-the-counter (OTC) drugs are medicines that may be sold without a prescription and without a visit to a medical professional, in contrast to prescription drugs. ... The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. ... Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA) In the USA, the Comprehensive Drug Abuse Prevention and Control Act of 1970 and subsequent modifications require the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs. ... This box:      The Controlled Substances Act (CSA) was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. ... The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. ... The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. ... The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ... The DEAs enforcement activities may take agents anywhere from distant countries to suburban U.S. homes. ... National Institutes of Health Building 50 at NIH Clinical Center - Building 10 The National Institutes of Health (NIH) is an agency of the United States Ministry of Health and Human Services and is the primary agency of the United States government responsible for biomedical and health-related research. ... The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. ... The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following: Is the drug... The Food and Drug Administrations Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. ... This box:      In health care, a clinical trial is a comparison test of a medication or other medical treatment (such as a medical device), versus a placebo (inactive look-a-like), other medications or devices, or the standard medical treatment for a patients condition. ... A randomized controlled trial (RCT) is a form of clinical trial, or scientific procedure used in the testing of the efficacy of medicines or medical procedures. ... Pharmacovigilance the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effect, of medicines (Source: The Importance of Pharmacovigilance, WHO 2002). ... The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical... The Uppsala Monitoring Centre (the UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. ... WHO redirects here. ... The Council for International Organizations of Medical Sciences (CIOMS) is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949. ... Single Convention on Narcotic Drugs Opened for signature March 30, 1961 at New York Entered into force December 13, 1964[1] Conditions for entry into force 40 ratifications Parties 180[2] The Single Convention on Narcotic Drugs is the international treaty against illicit drug manufacture and trafficking that forms the... The Institute of Medicine, a part of the National Academy of Sciences, is an American organization whose purpose is to provide national advice on issues relating to biomedical science, medicine, and health (National Academy of Sciences, n. ... The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. ...


New prescription drugs

New drugs receive extensive scrutiny before FDA approval and some continuing surveillance after marketing. The following sections outline the basic elements of the regulatory program.


Approval for testing in humans

To test a new drug experimentally in humans, a sponsor must first file Investigational New Drug Application (IND). The sponsor must show it has learned enough about the drug from animal and laboratory studies to give the drug safely to healthy volunteers. An IND is automatically approved unless the FDA objects. After an initial IND filing, a sponsor must submit annual reports, scientific reports about every study conducted and reports of adverse events.[7]


Approval to market a new drug

A New Drug Application (NDA) is request for approval to market a new drug for a specific indication or medical use. The first pivotal hurdle for approval is the legal requirement for "substantial" evidence of efficacy demonstrated through controlled clinical trials. [8] This standard lies at the heart of the regulatory program for drugs. It means that the clinical experience of doctors, the opinion of experts, or testimonials from patients, even if they have experienced a miraculous recovery, have no weight in this process. The second critical requirement is that the sponsor must prove the drug is safe "by all scientific means applicable." [8]This places the burden on the sponsor to conduct whatever tests may be needed to establish the safety of the drug product. In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...


However, prescription drugs are not completely safe. The legal requirements for safety and efficacy have been interpreted as requiring scientific evidence that the benefits of a drug outweigh the risks and that adequate instructions exist for its safe use. Many approved medications for serious illnesses (i.e. cancer) have severe and even life-threatening side effects.


The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [9]The prescribing information is widely available on the web, from the FDA, [10]drug manufacturers, and frequently inserted into drug packages.The main purpose of a drug label is to provide doctors with adequate information and directions for the safe use of the drug.


Chemistry and manufacturing

The FDA initial review of an NDA also includes a chemical assessment of the drug molecule. The sponsor must demonstrate a capacity to manufacture and package the drug at the specified potency without contamination or impurities and the with specified chemical characteristics (such as dissolution).


Advertising and promotion

The FDA reviews and regulates prescription drug advertising and promotion. (Other kinds of advertising, including for over-the- counter drugs, are regulated by the Federal Trade Commission). The drug advertising regulation[11] contains two key requirements. Under most circumstances, a company may only advertise a drug for the specific indication or medical use for which it was approved. Also, an advertisement must contain "fair balance" between the benefits and risks of a drug. | logo_caption = | seal = US-FederalTradeCommission-Seal. ...


Post market safety surveillance

After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis. [12] The FDA also receives directly adverse drug event reports through its MedWatch program.[13] These reports are called '"spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases the FDA is requiring risk management plans for some drugs that may provide for other kinds of studies, restrictions, or safety surveillance activities. drugs are good In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...


Generic drugs

Generic drugs are prescription drugs whose patent protection has expired, and therefore may be manufactured and marketed by other companies. For approval of a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable or therapeutically equivalent with the originally approved drug. [14]


Over-the-counter drugs

Over-the-counter (OTC) drugs are biologically active drugs and combinations that do not require a doctor's prescription. The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a physician's supervision. [15]


Biologics and blood products

The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.[16] These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a pre-market approval process similar to that for drugs. The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.helth The Center for Biologics Evaluation and Research (CBER) is one of five main centers for the United Statess Food and Drug Administration (US FDA). ... The Biologics Control Act was passed on July 1, 1902 after two incidents involving the deaths of children caused by contaminated vaccines. ... Table of Contents Public Health Service Act References are to Title 42 United States Code TITLE 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 6A - PUBLIC HEALTH SERVICE Subchapter I - Administration and Miscellaneous Provisions Part A - Administration § 201 Definitions Part B - Miscellaneous Provisions §238 Gifts for Benefit of Service §238a Use... The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. ... National Institutes of Health Building 50 at NIH Clinical Center - Building 10 The National Institutes of Health (NIH) is an agency of the United States Ministry of Health and Human Services and is the primary agency of the United States government responsible for biomedical and health-related research. ...


Medical and radiation-emitting devices

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.[17] The definition of a medical device is given in the aforementioned FD&C Act, and it includes products from the simple toothbrush to complex devices such as implantable brain pacemakers. The CDRH also oversees the safety performance of non-medical devices which emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products. The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. ... // COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices defines a ‘medical device’ as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for... Three toothbrushes The toothbrush is an instrument used to clean teeth, consisting of a small brush on a handle. ... Brain pacemakers are used to treat people who suffer from epilepsy, Parkinsons disease, clinical depression and other diseases. ... This box:      Electromagnetic (EM) radiation is a self-propagating wave in space with electric and magnetic components. ... Cellular redirects here. ... Baggage is scanned using X-ray machines, passengers walk through metal detectors Baggage screening monitoring at Bangkok Suvarnabhumi Airport Airport security refers to the techniques and methods used in protecting airports and by extension aircraft from crime and terrorism. ... TV redirects here. ... Microwave oven A microwave oven, or microwave, is a kitchen appliance employing microwave radiation primarily to cook or heat food. ... Image:Tanningbooth large. ... For other uses, see Laser (disambiguation). ...


CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. The CDRH also conducts limited amounts of direct product testing.


Cosmetics

Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not generally subject to pre-market approval by the FDA. However, all color additives must be specifically approved by the FDA before they can be included in cosmetic products sold in the U.S. The labeling of cosmetics is regulated by the FDA, and cosmetics which have not been subjected to thorough safety testing must bear a warning to that effect. The Center for Food Safety and Applied Nutrition is the branch of the Food and Drug Administration (FDA) which regulates food, dietary supplements, and cosmetics. ...


Veterinary products

The Center for Veterinary Medicine (CVM) is the branch of the FDA which regulates food, food additives, and drugs that are given to animals, including food animals and pets. CVM does not regulate vaccines for animals, these are handled by the USDA. The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. ... The U.S. Department of Agriculture, also called the Agriculture Department, or USDA, is a Cabinet department of the United States Federal Government. ...


CVM's primary focus is on medications that are used in food animals and ensuring that they do not affect the human food supply. FDA's requirements to prevent the spread of Mad Cow Disease are also administered by CVM through inspections of feed manufacturers. Bovine spongiform encephalopathy (BSE or commonly mad cow disease) is a fatal, neurodegenerative disease of cattle, which infects by a mechanism that shocked biologists on its discovery in late 20th century and appears transmissible to humans. ...


On [December 19], 2007, the FDA announced plans to create a database to track cloned animals through the food system and enable an effective labeling process [22]. This system will be part of the National Animal Identification System, which will track all livestock in the United States from farm to fork [23].


Important Enabling legislation

The Biologics Control Act was passed on July 1, 1902 after two incidents involving the deaths of children caused by contaminated vaccines. ... This is an article about the United States Food and Drug Act; for the Canadian version see Food and Drugs Act. ... The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. ... Table of Contents Public Health Service Act References are to Title 42 United States Code TITLE 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 6A - PUBLIC HEALTH SERVICE Subchapter I - Administration and Miscellaneous Provisions Part A - Administration § 201 Definitions Part B - Miscellaneous Provisions §238 Gifts for Benefit of Service §238a Use... The Fair Packaging and Labeling Act is a US law that applies to labels on many consumer products. ... The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. ... The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. ... A prescribed dietary supplement supplies nutrients (usually vitamins or minerals) that are missing or not consumed in sufficient quantity in a persons diet. ...

History

Early history

Origins of federal food and drug regulation

Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813. A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances. The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Although they had no regulatory powers, the Division published its findings from 1887 to 1902 in a ten-part series entitled Foods and Food Adulterants. Wiley used these findings, and alliances with diverse organizations such as state regulators, the General Federation of Women's Clubs, and national associations of physicians and pharmacists, to lobby for a new federal law to set uniform standards for food and drugs to enter into interstate commerce. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era.[18] The 1902 Biologics Control Act was put in place after tetanus antitoxin was collected from a horse named Jim who also had diphtheria, resulting in several deaths. Harvey Washington Wiley Harvey Washington Wiley (October 30, 1844, Kent, Indiana - June 30, 1930, Washington, D.C.) was a noted chemist involved with the passage of the landmark Pure Food and Drug Act of 1906. ... GFWC - General Federation of Womens Clubs For over 100 years GFWC members have been providing support to their communities by establishing over 75% of the countrys libraries, assisting in the creation of the National Park Service and establishing six national parks. ... The word physician should not be confused with physicist, which means a scientist in the area of physics. ... Pharmacists are health professionals who practice pharmacy. ... Article I, Section 8, Clause 3 of the United States Constitution empowers the United States Congress To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes. The Commerce Clause has been the subject of intense constitutional and political disagreement centering on the extent to... Bold text McClures Magazine (cover, Jan, 1901) published many early muckraker articles. ... Upton Sinclair Jr. ... In the United States, the Progressive Era was a period of reform which lasted from the 1890s to the 1920s. ...


The 1906 Food and Drugs Act and creation of the FDA

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate.[18] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated", with that term referring to the addition of fillers of reduced "quality or strength", coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary. The act also banned "misbranding" of food and drugs.[19] The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.[18] For other persons named Theodore Roosevelt, see Theodore Roosevelt (disambiguation). ...


Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, as well as by the creation of the Board of Food and Drug Inspection and the Referee Board of Consulting Scientific Experts as separate organizations within the USDA in 1907 and 1908 respectively. A 1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic efficacy,[20] in response to which a 1912 amendment added "false and fraudulent" claims of "curative or therapeutic effect" to the Act's definition of "misbranded." However, these powers continued to be narrowly defined by the courts, which set high standards for proof of fraudulent intent.[18] In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.[21] The Supreme Court of the United States (sometimes colloquially referred to by the acronym SCOTUS[1]) is the highest judicial body in the United States and leads the federal judiciary. ...


The 1938 Food, Drug, and Cosmetics Act

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which had been ruled permissible under the 1906 law, including radioactive beverages, cosmetics which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. The only way that the FDA could even seize the product was due to a misbranding problem: an "Elixir" was defined as a medication dissolved in ethanol, not the diethylene glycol used in the Elixir Sulfanilamide. Radioactive decay is the set of various processes by which unstable atomic nuclei (nuclides) emit subatomic particles. ... Make-up redirects here. ... This article is about the disease that features high blood sugar. ... Tuberculosis (abbreviated as TB for tubercle bacillus or Tuberculosis) is a common and deadly infectious disease caused by mycobacteria, mainly Mycobacterium tuberculosis. ... Congress in Joint Session. ... The Elixir Sulfanilamide disaster was a mass poisoning in the United States in 1937. ... Grain alcohol redirects here. ... Diethylene glycol (DEG) is an organic compound described by the structural formula HO-CH2-CH2-O-CH2-CH2-OH. It is a clear, hygroscopic, odorless liquid. ... The Elixir Sulfanilamide disaster was a mass poisoning in the United States in 1937. ...


President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 25, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. The law also authorized factory inspections and expanded enforcement powers, set new regulatory standards for foods, and brought cosmetics and therapeutic devices under federal regulatory authority. This law, though extensively amended in subsequent years, remains the central foundation of FDA regulatory authority to the present day.[18] Franklin Delano Roosevelt (January 30, 1882–April 12, 1945), 32nd President of the United States, the longest-serving holder of the office and the only man to be elected President more than twice, was one of the central figures of 20th century history. ... The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. ...


Regulation of human drugs and medical devices after 1938

Early FD&C Act amendments: 1938-1958

Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of 'prescription-only' drugs was securely codified into law by the 1951 Durham-Humphrey Amendment.[18] While pre-market testing of drug efficacy was not authorized under the 1938 FD&C Act, subsequent amendments such as the Insulin Amendment and Penicillin Amendment did mandate potency testing for formulations of specific lifesaving pharmaceuticals.[21] The FDA began enforcing its new powers against drug manufacturers who could not substantiate the efficacy claims made for their drugs, and the 1950 Court of Appeals ruling in Alberty Food Products Co. v. U.S. found that drug manufacturers could not evade the "false therapeutic claims" provision of the 1938 act by simply omitting the intended use of a drug from the drug's label. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.[18] Much of the FDA's regulatory attentions in this era were directed towards abuse of amphetamines and barbiturates, but the agency also reviewed some 13,000 new drug applications between 1938 and 1962. While the science of toxicology was in its infancy at the start of this era, rapid advances in experimental assays for food additive and drug safety testing were made during this period by FDA regulators and others.[18] Look up prescription in Wiktionary, the free dictionary. ... Court of Appeals or (outside the U.S. and in some American states) Court of Appeal is the title of a court which has the power to consider or hear an appeal. ... Toxicology (from the Greek words toxicos and logos [1]) is the study of the adverse effects of chemicals on living organisms [2]. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people. ...


Expansion of premarket approval process: 1959-1985

In 1959, Senator Estes Kefauver began holding congressional hearings into concerns about pharmaceutical industry practices, such as the perceived high cost and uncertain efficacy of many drugs promoted by manufacturers. There was significant opposition, however, to calls for a new law expanding the FDA's authority. This climate was rapidly changed by the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug - marketed for treatment of nausea - during their pregnancies. Thalidomide had not been approved for use in the U.S. due to the concerns of an FDA reviewer, Frances Oldham Kelsey. However, thousands of "trial samples" had been sent to American doctors during the "clinical investigation" phase of the drug's development, which at the time was entirely unregulated by the FDA. Individual members of Congress cited the thalidomide incident in lending their support to expansion of FDA authority.[22] The issue of Time Magazine in which Kefauvers victory in the New Hampshire primary was reported. ... This article is about the drug. ... Frances Oldham Kelsey (24 June 1914-) is a naturalized American pharmacologist most famous as a reviewer for the US Food and Drug Administration who refused to authorize thalidomide for market when she had serious concerns about the drugs safety. ...


The 1962 Kefauver-Harris Amendment to the FD&C act represented a "revolution" in FDA regulatory authority.[23] The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form. Drugs approved between 1938 and 1962 were also subject to FDA review of their efficacy, and to potential withdrawal from the market. Other important provisions of the 1962 amendments included the requirement that drug companies use the "established" or "generic" name of a drug along with the trade name, the restriction of drug advertising to FDA-approved indications, and expansion of FDA powers to inspect drug manufacturing facilities. The U.S. Kefauver Harris Amendment or Drug Efficacy Amendment of 1962 was a response to the Thalidomide tragedy in Europe. ...


One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. This act was intended to correct two unfortunate interactions between the new regulations mandated by the 1962 amendments, and existing patent law (which is not regulated or enforced by the FDA, but rather by the United States Patent and Trademark Office). Because the additional clinical trials mandated by the 1962 amendments significantly delayed the marketing of new drugs, without extending the duration of the manufacturer's patent, "pioneer" drug manufacturers experienced a decreased period of lucrative market exclusivity. On the other hand, the new regulations could be interpreted to require complete safety and efficacy testing for generic copies of approved drugs, and "pioneer" manufacturers obtained court decisions which prevented generic manufacturers from even beginning the clinical trial process while a drug was still under patent. The Hatch-Waxman Act was intended as a compromise between the "pioneer" and generic drug manufacturers which would reduce the overall cost of bringing generics to market and thus, it was hoped, reduce the long-term price of the drug, while preserving the overall profitability of developing new drugs. The act extended the patent exclusivity terms of new drugs, and importantly tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This act has been credited with essentially creating the modern generic drug industry.[24] The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. ... For other uses, see Patent (disambiguation). ... PTO headquarters in Alexandria The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent and trademark protection to inventors and businesses for their inventions and corporate and product identification. ... A generic drug (pl. ... Pharmacokinetics (in Greek: pharmacon meaning drug, and kinetikos meaning putting in motion) is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism. ...


FDA reforms in the AIDS era

Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests.[25] In August of 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.[26] For other uses, see AIDS (disambiguation). ... ACT-UP, or the Aids Coalition to Unleash Power, is a diverse, non-partisan group of individuals . ... Species Human immunodeficiency virus 1 Human immunodeficiency virus 2 Human immunodeficiency virus (HIV) is a retrovirus that causes acquired immunodeficiency syndrome (AIDS, a condition in humans in which the immune system begins to fail, leading to life-threatening opportunistic infections). ... [1] // Louis Cesare Lasagna was an internationally recognized and respected expert in clinical pharmacology. ...


Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options.[27] The first of these new rules was the "IND exemption" or "treatment IND" rule, which allowed expanded access to a drug undergoing phase II or III trials (or in extraordinary cases even earlier) if it potentially represented a safer or better alternative to treatments currently available for terminal or serious illness. A second new rule, the "parallel track policy", allowed a drug company to set up a mechanism for access to a new potentially lifesaving drug by patients who for various reasons would be unable to participate in ongoing clinical trials. The "parallel track" designation could be made at the time of IND submission. The accelerated approval rules were further expanded and codified in 1992.[28]


All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted just two years later in 1987.[29] Three of the first five drugs targeting HIV were approved in the United States before they were approved in any other country.[30] Zidovudine (INN) or azidothymidine (abbreviated to AZT) is an anti-retroviral drug, the first antiviral treatment to be approved for use against HIV. It is also sold under the names Retrovir and Retrovis, and as an ingredient in Combivir and Trizivir. ...


Recent and ongoing reforms

Patients' rights to access unapproved drugs

An ongoing court case, Abigail Alliance v. von Eschenbach, has the potential to force radical changes in FDA regulation of unapproved drugs. Abigail Burroughs was a college student diagnosed with head and neck cancer. During the later phases of her treatment, Abigail's father sued the FDA for access to the novel biotechnology drug cetuximab. At that time, cetuximab was available experimentally only for patients participating in colon cancer clinical trials (it has since been approved for colon cancer, as well as head and neck cancer when combined with radiation therapy). The argument made by the Abigail Alliance in court is that terminal cancer patients have a Constitutionally protected right to access to experimental medications before the FDA approves them. Specifically, the Abigail Alliance argued that the FDA should license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing.[31] Abigail Alliance for Better Access to Developmental Drugs v. ... Head and neck cancers are malignant growths originating in the lip and oral cavity (mouth), nasal cavity, pharynx, larynx, thyroid, paranasal sinuses, salivary glands and cervical lymph nodes of the neck. ... Cetuximab (Erbitux®) is a chimeric monoclonal antibody given by intravenous injection for treatment of colorectal cancer. ... Colorectal cancer, also called colon cancer or bowel cancer, includes cancerous growths in the colon, rectum and appendix. ... In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...


In May 2006, the U.S. Court of Appeals for the District of Columbia ruled in favor of the Abigail Alliance, and found that the US Constitution protects the right of terminally ill patients to access treatments that are not approved by the FDA. On March 1, 2007, the U.S. Court of Appeals was scheduled to rehear the case at the request of the FDA. This case has the potential to radically alter the conduct of clinical cancer research, since the initial Court of Appeals ruling essentially condones unfettered access to experimental drugs by terminally ill patients, who would then have little incentive to enter Phase II and Phase III clinical trials testing new cancer drugs. The American Society of Clinical Oncology (ASCO) filed an amicus brief to the U.S. Court of Appeals in advance of the March 1 hearing, supporting the FDA. ASCO proposes that the Constitution does not guarantee the right to access unapproved medications, and that the court case threatens the cancer clinical trial enterprise.[32] Star Trek: Phase II, or Star Trek II was a planned television series based on the characters of Gene Roddenberrys Star Trek. ... In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ... In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...


Post-marketing drug safety monitoring

The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999, and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of gastrointestinal tract bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004.[33] Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials[34] for reforms in the FDA's procedures for pre- and post- market drug safety regulation. Image File history File links This is a lossless scalable vector image. ... Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that was used in the treatment of osteoarthritis, acute pain conditions, and dysmenorrhoea. ... Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. ... Heart attack redirects here. ...


In 2006, a congressionally requested committee was appointed by the Institute of Medicine to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.[35][36] Some of the committee’s recommendations have been incorporated into drafts of the PDUFA IV bill which is expected to be passed by Congress in 2007. The Institute of Medicine, a part of the National Academy of Sciences, is an American organization whose purpose is to provide national advice on issues relating to biomedical science, medicine, and health (National Academy of Sciences, n. ... Biostatistics or biometry is the application of statistics to a wide range of topics in biology. ... A pharmaceutical company, or drug company, is a commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. ... The term health insurance is generally used to describe a form of insurance that pays for medical expenses. ...


Pediatric drug testing

Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of pediatricians as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. The reasons for the dearth of clinical drug testing in children were multifactorial. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective. Also, because children were thought to be ethically restricted in their ability to give informed consent, there were increased governmental and institutional hurdles to approval of these clinical trials, as well as greater concerns about legal liability. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations.[37] Pediatrics (also spelled paediatrics or pædiatrics) is the branch of medicine that deals with the medical care of infants and children. ... Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. ... In the most general sense, a liability is anything that is a hindrance, or puts individuals at a disadvantage. ...


An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs which had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications. However, this new rule was successfully preempted in Federal court as exceeding the FDA's statutory authority. While this debate was unfolding, Congress used the 1997 Food and Drug Administration Modernization Act to pass incentives which gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The act reauthorizing these provisions, the 2002 Best Pharmaceuticals for Children Act, allowed the FDA to request NIH-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. Most recently, in the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.[37]


Rules for generic biologics

Since the 1990s, many successful new drugs for the treatment of cancer, autoimmune diseases, and other conditions have been protein-based biotechnology drugs, regulated by the Center for Biologics Evaluation and Research. Many of these drugs are extremely expensive; for example, the anti-cancer drug Avastin costs $55,000 for a year of treatment, while the enzyme replacement therapy drug Cerezyme costs $200,000 per year, and must be taken by Gaucher's Disease patients for life. Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process, essentially precluding the possibility of generic drug competition for biotechnology drugs. In February of 2007, identical bills were introduced into the House[38] and Senate[39] with bipartisan cosponsorship to create an ANDA process for the approval of generic biologics. The bills face opposition from biologic drug manufacturers, and other lawmakers are working to create compromise legislation.[40] Cancer is a class of diseases or disorders characterized by uncontrolled division of cells and the ability of these to spread, either by direct growth into adjacent tissue through invasion, or by implantation into distant sites by metastasis (where cancer cells are transported through the bloodstream or lymphatic system). ... Autoimmunity is the failure of an organism to recognize its own constituent parts (down to the sub-molecular levels) as self, which results in an immune response against its own cells and tissues. ... A representation of the 3D structure of myoglobin showing coloured alpha helices. ... Biologics or biologic therapies are a new class of drugs produced through genetic manipulation. ... The Center for Biologics Evaluation and Research (CBER) is one of five main centers for the United Statess Food and Drug Administration (US FDA). ... Bevacizumab is an anti-angiogenesis drug used in treatment of cancer. ... Enzyme replacement therapy is a medical treatment replacing an enzyme in patients in whom that particular enzyme is deficient or absent. ... Imiglucerase is a recombinant DNA produced analogue of human β-glucocerebrosidase. ... Gauchers disease (IPA: ) is the most common of the lysosomal storage diseases. ... The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. ...


Criticism

Main article: Criticism of the Food and Drug Administration

The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens.[18] As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. There are many criticisms and complaints lodged against the FDA from patients, economists, regulatory bodies, and the pharmaceutical industry.


FDA commissioners

  • Andrew von Eschenbach — current commissioner
  • Lester Crawford 7/2005 - 9/2005
  • Mark McClellan 11/2002 - 3/2004
  • Jane E. Henney 1/1999 - 1/2001
  • David Aaron Kessler 11/1990 - 2/1997
  • Frank Edward Young 7/1984 - 12/1989
  • Arthur Hull Hayes 4/1981 - 9/1983
  • Jere E. Goyan 10/1979 - 1/1981
  • Donald Kennedy 4/1977 - 6/1979
  • Alexander M. Schmidt 7/1973 - 10/1976
  • Charles C. Edwards 12/1969 - 3/1973
  • Herbert L. Ley 7/1968 - 12/1969
  • James L. Goddard 1/1966 - 7/1968
  • George P. Larrick 8/1954 - 12/1965
  • Charles W. Crawford 6/1951 - 7/1954
  • Paul P. Dunbar 5/1944 - 5/1951
  • Walter G. Campbell 7/1927 - 4/1944 and 7/1921 - 6/1924
  • Charles A. Browne 7/1924 - 6/1927
  • Carl L. Alsberg 12/1912 - 7/1921
  • Harvey W. Wiley 1/1907 - 3/1912

Andrew C. von Eschenbach (born October 30, 1941 in Philadelphia, Pennsylvania) is the current Commissioner of the United States Food and Drug Administration. ... Dr. Lester M Crawford Dr. Lester M. Crawford (born 1939) is a former Commissioner of the United States Food and Drug Administration (FDA). ... Dr. Mark B. McClellan Mark B. McClellan (born June 26, 1963) was sworn in as Administrator for the Centers for Medicare and Medicaid Services in the United States Department of Health and Human Services on March 25, 2004. ... Jane E. Henney is an American physician who was the first woman to serve as commissioner of the U.S. Food and Drug Administration. ... American physician, lawyer, and statesman. ... For the recipient of the Victoria Cross see Frank Edward Young (VC) Frank Edward Young (born 1931) was a U.S. administrator and physician. ... Donald Kennedy is an American scientist, public administrator and academic. ... Senator Walter G. Skip Campbell (born November 12, 1948) is a member of the Florida Senate from Tamarac, Florida. ... Harvey Washington Wiley Harvey Washington Wiley (October 30, 1844, Kent, Indiana - June 30, 1930, Washington, D.C.) was a noted chemist involved with the passage of the landmark Pure Food and Drug Act of 1906. ...

See also

This was a program begun by the FDA in the 1960s after the requirement that all drugs be efficacious as well as safe. ... The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical... An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a... The University of Florida’s Institute of Food and Agricultural Sciences (UF/IFAS) is a federal-state-county partnership dedicated to developing knowledge in agriculture, human and natural resources, and the life sciences, and enhancing and sustaining the quality of human life by making that information accessible. ... The U.S. Kefauver Harris Amendment or Drug Efficacy Amendment of 1962 was a response to the Thalidomide tragedy in Europe. ... A pharmaceutical company, or drug company, is a commercial business whose focus is to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. ... The Medical Letter on Drugs and Therapeutics, commonly referred to simply as The Medical Letter, provides independent, unbiased critical evaluations of new drugs and sometimes older drugs when important new information becomes available. ... The logo of the MHRA. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. ...

Further reading

  • Michael Givel (December 2005) Philip Morris’ FDA Gambit: Good for Public Health? Journal of Public Health Policy (26): pp. 450-468.
  • Philip J. Hilts. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred E. Knopf, 2003. ISBN 0-375-40466-X
  • Thomas J. Moore. Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet. New York: Simon & Schuster, 1998. ISBN 0-684-82998-3.

References

  1. ^ Food, Drug and Cosmetic Act Web Version [1]
  2. ^ Summary of FDA’s FY 2008 Budget
  3. ^ http://www.cfsan.fda.gov/~lrd/cfsan4.html Overview of the Center for Food Safety and Applied Nutrition
  4. ^ Text of the Dietary Supplement Health and Education Act of 1994. Accessed 5 Feb 2007.
  5. ^ [2]PDF (106 KiB) Title 21 of the Code of Federal regulations
  6. ^ http://www.dwrf.info/documents/recent_dev_bw_quality.pdfPDF (217 KiB)
  7. ^ 21 CFR Part 312: Investigational New Drug Application
  8. ^ a b Food, Drug, and Cosmetic Act, Section 502; 21 USC 355]
  9. ^ 21 CFR 201.5: Labeling Requirements for Prescription Drugs and/or Insulin
  10. ^ Daily Med: Current Medication Information. Retrieved on October 10, 2007.
  11. ^ 21 CFR 202: Prescription Drug Advertising.
  12. ^ 21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences
  13. ^ MedWatch: The FDA Safety Information and Adverse Event Reporting Program[3]. Accessed October 9, 2007
  14. ^ Therapeutic Equivalence of Generic Drugs. U.S. Food and Drug Administration (1998). Retrieved on 2007-10- 10.
  15. ^ FDA CDER Handbook: Over-the- Counter Drug Products [4] Accessed October 9, 2007
  16. ^ FDA/CBER - About CBER
  17. ^ 2005 report of the CDRH Radiological Health Program Core GroupPDF (90.3 KiB)
  18. ^ a b c d e f g h i [5] A History of the FDA at FDA.gov
  19. ^ [6] Original Text of the 1906 Food and Drugs Act and Amendments
  20. ^ United States v. Johnson, [6df1b297de555a5c 221 U.S. 488] (31 S. Ct. 627 May 29, 1911, decided).
  21. ^ a b [7] Milestones in U.S. Food and Drug Law History at FDA.gov
  22. ^ [8] Report of Congressman Morris Udall on thalidomide and the Kefauver hearings.
  23. ^ Temple R (2002). "Policy developments in regulatory approval". Statistics in Medicine 21: 2939-2948. 
  24. ^ Karki L (2005). "Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman Act, Regulatory Amendments and Implications for Drug Patent Enforcement". Journal of the Patent & Trademark Office Society 87: 602-620. 
  25. ^ [9] ACT-UP NY timeline
  26. ^ Faster Approval of AIDS Drugs Is Urged, The New York Times, August 16, 1990, Thursday, Late Edition - Final, Section B; Page 12, Column 4; National Desk, 830 words, By ROBERT PEAR, Special to The New York Times, WASHINGTON, Aug. 15
  27. ^ [10] FDA Website: Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS
  28. ^ Orlando V (1999). "The FDA's Accelerated Approval Process: Does the Pharmaceutical Industry Have Adequate Incentives for Self-Regulation?". American Journal of Law and Medicine 25: 543-68. 
  29. ^ [11] FDA report on accelerated approval process
  30. ^ [12] FDA press release on 3TC approval
  31. ^ [13]PDF (119 KiB) Abigail Alliance Citizen Petition to FDA
  32. ^ [14]PDF (1.14 MiB) Amicus brief by ASCO, filed February 2007
  33. ^ [15] The APPROVe study (Pubmed)
  34. ^ [16]PDF (28.3 KiB) David Graham's 2004 testimony to Congress
  35. ^ Henderson, Diedtra. "Panel: FDA needs more power, funds", Boston Globe, September 23, 2006.  [17]
  36. ^ [18]PDF (279 KiB) Executive Summary of the 2006 IOM Report The Future of Drug Safety: Promoting and Protecting the Health of the Public
  37. ^ a b Politis P (2005). "Transition From the Carrot to the Stick: The Evolution of Pharmaceutical Regulations Concerning Pediatric Drug Testing". Widener Law Review 12: 271. 
  38. ^ [19] H. R. 1038: Access to Life-Saving Medicine Act. (Introduced 2/14/2007)
  39. ^ [20] S. 623: Access to Life-Saving Medicine Act. (Introduced 2/14/2007)
  40. ^ [21] Pear R. Congress Seeks Compromise on Generic Drugs. New York Times (April 7, 2007)

“PDF” redirects here. ... A kibibyte (a contraction of kilo binary byte) is a unit of information or computer storage, commonly abbreviated KiB (never kiB). 1 kibibyte = 210 bytes = 1,024 bytes The kibibyte is closely related to the kilobyte, which can be used either as a synonym for kibibyte or to refer to... “PDF” redirects here. ... A kibibyte (a contraction of kilo binary byte) is a unit of information or computer storage, commonly abbreviated KiB (never kiB). 1 kibibyte = 210 bytes = 1,024 bytes The kibibyte is closely related to the kilobyte, which can be used either as a synonym for kibibyte or to refer to... Year 2007 (MMVII) was a common year starting on Monday of the Gregorian calendar in the 21st century. ... “PDF” redirects here. ... A kibibyte (a contraction of kilo binary byte) is a unit of information or computer storage, commonly abbreviated KiB (never kiB). 1 kibibyte = 210 bytes = 1,024 bytes The kibibyte is closely related to the kilobyte, which can be used either as a synonym for kibibyte or to refer to... Lamivudine(2-3-dideoxy-3-thia cytidine, 3TC) is a potent reverse transcriptase inhibitor. ... “PDF” redirects here. ... A kibibyte (a contraction of kilo binary byte) is a unit of information or computer storage, commonly abbreviated KiB (never kiB). 1 kibibyte = 210 bytes = 1,024 bytes The kibibyte is closely related to the kilobyte, which can be used either as a synonym for kibibyte or to refer to... “PDF” redirects here. ... MiB redirects here. ... “PDF” redirects here. ... A kibibyte (a contraction of kilo binary byte) is a unit of information or computer storage, commonly abbreviated KiB (never kiB). 1 kibibyte = 210 bytes = 1,024 bytes The kibibyte is closely related to the kilobyte, which can be used either as a synonym for kibibyte or to refer to... “PDF” redirects here. ... A kibibyte (a contraction of kilo binary byte) is a unit of information or computer storage, commonly abbreviated KiB (never kiB). 1 kibibyte = 210 bytes = 1,024 bytes The kibibyte is closely related to the kilobyte, which can be used either as a synonym for kibibyte or to refer to...

External links

Food and Drug Administration websites

  • Food and Drug Administration Home Page
    • Biologics Centennial: 100 Years of Biologics Regulation — from the Food and Drug Administration Home Page
    • U.S. FDA CDER Home Page — the Center for Drug Evaluation and Research
    • CBER — Center for Biologics Evaluation and Research, FDA
    • Past FDA Commissioners
  • Communication of FDA Advice on Consumption of Fish Like Tuna and Swordfish
The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ... The United States Secretary of Health and Human Services is the head of the United States Department of Health and Human Services, concerned with The Secretary is a member of the Presidents Cabinet. ... Image File history File links US-DeptOfHHS-Logo. ... The United States Assistant Secretary for Health (ASH) serves as the Secretary of Health and Human Servicess primary advisor on matters involving the nations public health. ... Template:Higher standard // History of the United States Public Health Service The United States Public Health Service (PHS) was founded first by President John Adams in 1798 as a loose network of hospitals to support the health of American seamen. ... The Office of Public Health and Science (OPHS) is an agency of the United States Department of Health and Human Services. ... The Administration for Children and Families (ACF) is a division of the United States Department of Health and Human Services (HHS). ... The Administration on Aging agency in the United States Department of Health and Human Services (HHS) conducts statistical activities in support of the research, analysis, and evaluation of programs to meet the needs of an aging population. ... The Agency for Healthcare Research and Quality (AHRQ), formerly known as the Agency for Health Care Policy and Research (AHCPR), supports research designed to improve the outcomes and quality of health care, reduce its costs, address patient safety and medical errors, and broaden access to effective services. ... The United States Agency for Toxic Substances and Disease Registry, (ATSDR), is directed by congressional mandate to perform specific functions concerning the effect on public health of hazardous substances in the environment. ... The Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, is recognized as the leading United States agency for protecting the public health and safety of people. ... It has been suggested that Health Care Financing Administration be merged into this article or section. ... The Health Resources and Services Administration (HRSA), a division of the United States Department of Health and Human Services, envisions optimal health for all, supported by a health care system that assures access to comprehensive, culturally competent, quality care. ... The Indian Health Service (IHS), an agency within the U.S. Department of Health and Human Services, is responsible for providing federal health services to American Indians and Alaska Natives. ... National Institutes of Health Building 50 at NIH Clinical Center - Building 10 The National Institutes of Health (NIH) is an agency of the United States Ministry of Health and Human Services and is the primary agency of the United States government responsible for biomedical and health-related research. ... Substance Abuse and Mental Health Services Administration (SAMHSA) is the US Federal agency charged with improving the quality and availability of prevention, treatment, and rehabilitative services in order to reduce illness, death, disability, and cost to society resulting from substance abuse and mental illnesses. ... PHS Cap Device The United States Public Health Service Commissioned Corps (PHSCC), also known as the Meditary, is the uniformed division of the United States Public Health Service (PHS) and one of the seven Uniformed Services of the United States. ...

  Results from FactBites:
 
Food and Drug Administration - Wikipedia, the free encyclopedia (3967 words)
The FDA is divided into five major Centers: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
FDA regulations are blamed for causing high drug prices, keeping life-saving drugs off the market, prohibiting access to emergency contraceptives, allowing unsafe drugs on the market because of pressure from pharmaceutical companies, and censoring health information about nutritional supplements and foods.
The FDA went to court in 1956 to act against the interstate shipment of "orgone accumulators", an experimental device built by an aging Dr. Wilhelm Reich.
Food and Drug Administration - MSN Encarta (417 words)
FDA inspectors periodically visit facilities and warehouses, and agency chemists analyze the samples that inspectors collect.
Food additives must be generally recognized as safe or proven safe by scientific tests.
Residues of pesticide chemicals in food commodities must not exceed safe tolerances, which are established by the Environmental Protection Agency and enforced by the FDA.
  More results at FactBites »

 
 

COMMENTARY     


Share your thoughts, questions and commentary here
Your name
Your comments

Want to know more?
Search encyclopedia, statistics and forums:

 


Press Releases |  Feeds | Contact
The Wikipedia article included on this page is licensed under the GFDL.
Images may be subject to relevant owners' copyright.
All other elements are (c) copyright NationMaster.com 2003-5. All Rights Reserved.
Usage implies agreement with terms, 1022, m