Investigational new drug
The United States
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.
Criteria for application
A clinical study requires an IND if it is intended to support a:
* New indication
* Change in the approved
route of administrationor dosage level
* Change in the approved patient
population(e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised)
* Significant change in the promotion of an approved drug
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).
*"Chemistry and Manufacturing Information" - Information pertaining to the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. The chemical
stabilityand activity of the product must also have been tested. This information is assessed to ensure that the company can adequately produce and supply consistent and active 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.
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 institutional 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.
* Experimental drugs under an IND must be labeled, "Caution: New Drug--Limited by Federal (or United States) law to investigational use."
The FDA closed its
medical marijuanaIND program (the Compassionate Investigational New Drug program) in 1991, facing an influx of AIDSpatients seeking access to the drug. Seven patients continue to receive cannabisfrom the government under the program [http://www.medmjscience.org/Pages/science/ucsfnews.html] .
New drug application
Expanded access("compassionate use")
FDA Fast Track Development Program
* [http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm Investigational New Drug (IND) Application Process] Center for Drug Evaluation and Research, Food and Drug Administration.
* [http://www.fda.gov/cder/guidance/959fnl.pdf ICH Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance.]
*Krieger, Lisa M.: [http://www.medmjscience.org/Pages/science/ucsfnews.html Study Targets Stalemate Over Medicinal Use of Marijuana] , San Jose Mercury News, July 19, 1998.
*Troetel, W.M.: Achieving a Successful US IND Filing (1) The Regulatory Affairs Journal. 6: 22-28, January 1995.
*Troetel, W.M.: Achieving a Successful US IND Filing (2) The Regulatory Affairs Journal. 6: 104-108, February 1995.
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