References for CMC Guidances

The following list contains relevant CMC guidances, draft and final, related to the regulatory and compliance documents required by the FDA for U.S. submissions and by the ICH for international dossiers. Although some of the listed guidances are in draft form, they represent FDA s current thinking and are useful references. 

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

INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products Chemistry, Manufacturing and Controls Content and Format, February 1999 (Draft) 

IND Meetings for Human Drugs and Biologies Chemistry, Manufacturing and Controls Information, February 2000 (Draft) 

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