The Food and Drug Administration's 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. The FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk. FDA logo The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. ...
The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
The FDA closed its medical marijuana IND program (the Compassionate Use Program) in 1992, facing an influx of AIDS patients seeking access to the drug. Seven patients continue to receive cannabis from the government under the program. Cannabis sativa extract. ... The Compassionate Use Program is the Investigational New Drug program allowing a limited number of patients to use National Institute on Drug Abuse-provided medical marijuana grown at the University of Mississippi. ... 1992 is a leap year starting on Wednesday of the Gregorian calendar. ... The Red Ribbon symbol is used internationally to represent the fight against AIDS. AIDS (Acquired Immunodeficiency Syndrome or Acquired Immune Deficiency Syndrome, rarely written Aids) is the result of infection with Human immunodeficiency virus HIV, a lentivirus. ... Species Cannabis sativa Cannabis indica Cannabis ruderalis Cannabis is a plant genus which includes the species Cannabis sativa, also known as hemp, though this term is usually only used to refer to non-drug use. ...
Center for Drug Evaluation and Research, Food and Drug Administration.
Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
The label or labeling of an investigationalnewdrug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigationalnewdrug is safe or effective for the purposes for which it is being investigated.
Investigationaldrugs are to be administered in accordance with research protocol and in accordance with any other hospital or clinic policy pertaining to the administration of medications.
An investigationalnewdrug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
If the investigation involves an exception from informed consent under § 50.24 of this chapter, the sponsor shall prominently identify on the cover sheet that the investigation is subject to the requirements in § 50.24 of this chapter.
Any adverse drug experience, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.
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