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Drugs

Investigational New Drug Applications

Below is a sortable listing of Investigational New Drug Applications Guidances

CategoryTitleTypeDate
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB) Final Guidance 11/01/95
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers (PDF - 14KB) Final Guidance 10/01/00
Investigational New Drug Applications Exploratory IND Studies (PDF - 220KB) Final Guidance 01/12/06

Page Last Updated: 09/01/2015
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