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This guidance has been superseded by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

Drug Safety Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 501KB) Final Guidance 05/14/13
Drug Safety Classifying Significant Posmarketing Drug Safety Issues (PDF - 288KB) Draft Guidance 03/08/12
Drug Safety Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB) Final Guidance 07/29/09
Drug Safety Format and Content of a REMS Document Guidance for Industry (PDF - 240KB) Draft Guidance 10/11/17
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
Drug Safety Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF - 290KB) Final Guidance 04/11/18
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 Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF - 116KB) Final Guidance 11/28/16
Drug Safety Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (PDF - 608KB) Draft Guidance 04/23/13
Drug Safety Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (PDF - 118KB) Final Guidance 07/30/13
Drug Safety Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies (PDF - 227KB) Final Guidance 12/19/12
Drug Safety Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide (PDF - 35KB) Final Guidance 12/19/12
Drug Safety Best Practices in Developing Proprietary Names for Drugs (PDF - 279KB) Draft Guidance 05/28/14
Drug Safety Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen (PDF - 82KB) Final Guidance 08/04/15
Compounding/Drug Safety Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 434KB) Final Guidance 09/28/18
Drug Safety Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry (PDF - 196KB) Draft Guidance 04/06/15
Drug Safety Safety Assessment for IND Safety Reporting Guidance for Industry (PDF - 411KB) Draft Guidance 12/16/15
Drug Safety Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry (PDF - 212KB) Final Guidance 04/11/16
Drug Safety FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry (PDF - 129KB) Draft Guidance 09/20/16
Drug Safety Development of a Shared System REMS Guidance for Industry (PDF - 99KB) Draft Guidance 05/31/18
Drug Safety Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry (PDF - 91KB) Draft Guidance 05/31/18
Drug Safety; Biostatistics Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry (PDF - 227KB) Draft Guidance 11/06/18

Page Last Updated: 11/06/2018
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