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U.S. Department of Health and Human Services

Drugs

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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 - 1516KB)

This guidance has been superseded by

Attachment B: Clinical Safety Review of an NDA or BLA of the Good Review Practice: Clinical Review Template (MAPP 6010.3 Rev. 1) that posted Dec 15, 2010
Final

2/2005

Removed 1/26/2011

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 2007Final1/21/2009
Pharmacology/Toxicology Review Format (PDF - 55KB)  

Final

5/2001