The FDA's new procedures for the use of investigational drugs in treatment.
The Food and Drug Administration has established new procedures to make promising investigational drugs available for treatment of patients with immediately life-threatening or serious diseases as early in the drug development process as possible and well before general marketing begins. The purpose of this article is to inform the medical community about these new procedures and to facilitate their implementation. Examples of immediately life-threatening and serious diseases are given and the procedures that physicians should use to obtain a drug under the new regulations are described. The treatment use of zidovudine (Retrovir), while still in the investigational phase, is described as a case study. The article also summarizes the Food and Drug Administration's new procedures under which drug sponsors can charge for investigational drugs.
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Office of Health Affairs, Food and Drug Administration, Rockville, MD 20857.
Norris
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Levitt
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Nightingale
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D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D002388:Catastrophic Illness / Q000188:drug therapy*; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods; D004346:Drug Information Services; D006801:Humans; D007258:Informed Consent; D009965:Orphan Drug Production; D004364:Pharmaceutical Preparations; D011786:Quality Control; D013936:Thymidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration; D015215:Zidovudine
D004364:Pharmaceutical Preparations; D015215:Zidovudine; D013936:Thymidine