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Good Review Practices
Title and Format
Type
Issue Date
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF - 1516 KB)
Final
2/2005
Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff : Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007
Final
1/21/2009
Pharmacology/Toxicology Review Format (PDF - 55 KB)
Final
5/2001
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