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Drugs

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Drug Safety

Below is a sortable table of Drug Safety Guidances

Note: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This guidance has been superseded by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 was posted on Dec 15, 2010

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Category	Title	Type	Date
Drug Safety	Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 316KB)	Draft Guidance	02/16/11
MAPP 6010.3R attachment	Attachment B: Clinical Safety Review of an NDA or BLA (PDF - 1.1MB)
Drug Safety	Classifying Significant Posmarketing Drug Safety Issues (PDF - 288KB)	Draft Guidance	03/08/12
Drug Safety	Drug Safety Information -- FDA's Communication to the Public (PDF - 449KB)	Draft Guidance	03/08/12
Drug Safety	Drug Safety Information - FDA's Communication to the Public (PDF - 114KB)	Final Guidance	03/02/07
Drug Safety	Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)	Final Guidance	07/29/09
Drug Safety	Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 41KB)	Final Guidance	06/06/11
Drug Safety	Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (PDF - 316KB)	Draft Guidance	10/01/09
Drug Safety	Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events (PDF - 67KB)	Final Guidance	06/08/09
Drug Safety	Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) (PDF - 91KB)	Final Guidance	11/17/11
Procedural; Drug Safety	Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage (PDF - 226KB)	Draft Guidance	02/21/12
Drug Safety	Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF - 218KB)	Final Guidance	02/23/12
Drug Safety	Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act (PDF - 276KB)	Final Guidance	03/31/11
Drug Safety	Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (PDF - 129KB)	Draft Guidance	04/12/11
Drug Safety	Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies (PDF - 687KB)	Draft Guidance	09/28/10

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