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Safety Review of a New Product Application and Preparing a Report on the Review (PDF - 1516KB) This guidance has been superseded by Attachment B: Clinical Safety Review of an NDA or BLA of the Good Review Practice: Clinical Review Template (MAPP 6010.3 Rev. 1) that posted Dec 15, 2010 |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 2007 | Final | 1/21/2009 |
| Pharmacology/Toxicology Review Format (PDF - 55KB) | Final | 5/2001 |
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