Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products Guidance for Industry November 1995

With FDA's recent successes in meeting the Prescription Drug User Fee Act of 1992 (PDUFA) review action performance goals, and the resulting significant declines in mean and median time from submission of a marketing application to approval for marketing, attention has turned to increasing the efficiency of other components of the drug development process without sacrificing the longstanding safety and efficacy standards Americans expect their drug products to meet. One part of IND regulation of particular interest - under active discussion for more than two years and the subject of various degrees of attention since the McMahon Committee - is the regulation of the initial testing of drugs in humans (i.e., Phase 1 trials).

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All written comments should be identified with this document's docket number: FDA-1995-D-0251.