| Investigational New Drug |
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Information AboutInvestigational New Drug |
| CATEGORIES ABOUT INVESTIGATIONAL NEW DRUG | |
| united states department of health and human services | |
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CRITERIA FOR APPLICATION A clinical study requires an IND if it is intended to support a:
APPLICATION CONTENTS 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. APPLICATION CATEGORIES 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. ADDITIONAL REGULATIONS
Drug--Limited by Federal (or United States) law to investigational use." NOTEWORTHY EXAMPLES 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 {Link without Title} . SEE ALSO
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