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Investigational New Drug
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 application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.
Additional recommended knowledge
Criteria for application
A clinical study requires an IND if it is intended to support a:
The IND application must contain information in three broad areas:
An IND must also include an Investigator's Brochure which is a document intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients who will be enrolled.
There are two main categories of IND: Investigator-initiated, and Sponsor-initiated. Investigator-initiated INDs are used when a physician wishes to perform a clinical trial to study an unapproved drug treatment, for example a new indication for an existing drug. Sponsor-initiated INDs are filed by pharmaceutical companies studying new drugs or new uses for existing drugs. Both of these types of studies require approval by an insitutional review board (IRB), an independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial. The IRB must review, approve, and provide continuing review of the trials, protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Drug--Limited by Federal (or United States) law to investigational use."
The FDA closed its medical marijuana IND program (the Compassionate Investigational New Drug program) in 1991, facing an influx of AIDS patients seeking access to the drug. Seven patients continue to receive cannabis from the government under the program .
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Investigational_New_Drug". A list of authors is available in Wikipedia.|