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
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
November 1, 1995
May 6, 2020
ecc5878c-4062-49df-90cc-6ac91b3adb4c
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