In accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), this website contains links to postmarket drug safety information to improve transparency and communication to patients and healthcare providers.
Latest Safety Information
Index to Drug-Specific Information
For patients, consumers, and healthcare professionals, provides links to safety sheets with the latest risk information about particular drugs, related press announcements, and other fact sheets.
Drug Safety Communications News & Events
Includes drug safety announcements from CDER and MedWatch.
MedWatch Safety Alerts for Human Medical Products FDA Drug Safety Podcasts
Provides emerging safety information about particular drugs in conjunction with the release of Public Health Advisories.
Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) FDA Adverse Event Reporting System (FAERS)
Provides a description of FAERS, FAERS data files, FAERS summary statistics and other information.
Postmarket Drug and Biologic Safety Evaluations
Postmarketing safety summaries of recently approved drug and biologic products.
- Postmarketing Safety Evaluation of New Molecular Entities: Final Report (10/15/2009)
Studies and Clinical Trials of Approved Products
Postmarket Requirements and Commitments Search
Searchable database of CDER and CBER commitments. (updated quarterly)
Risk Evaluation and Mitigation Strategies (REMS)
- REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS)
Database of Approved REMS
REMS Integration Initiative CDER SBIA Webinar - Risk Evaluation and Mitigation Strategies: Modifications and Revisions - Guidance for Industry - April 7, 2015 DDI Webinar- “Introducing the REMS@FDA Website”- June 23, 2015
- Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) (PDF - 91KB)
Guidance for Industry (issued 11/17/2011)
- Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications(PDF - 316KB)
Draft Guidance for Industry (issued 9/30/2009)
Template for Proposed REMS and REMS Supporting Document for a REMS that includes Only a Medication Guide and Timetable for Submission of Assessments(PDF - 20KB) Template for Proposed REMS and REMS Supporting Document for a REMS that includes elements Other Than only a Medication Guide and Timetable for Submission of Assessments(PDF - 31KB) Risk Evaluation and Mitigation Strategies (REMS) Letters to Sponsor/Applicants Requesting Labeling Changes
- Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies
Federal Register Notice (3/27/2009)
Information about FDA's Drug Safety Oversight Board (DSB)
General Health Information
Authoritative drug and health information from the National Institutes of Health (NIH), and other government agencies and health-related organizations.
FDA's Response to the Institute of Medicine's 2006 Report
Approved Professional, Patient Labeling, and Patient Package Inserts in Drugs@FDA
DailyMed (National Library of Medicine)
Drug labeling on this Web site is the most recent submitted to FDA and currently in use; it may include, for example, strengthened warnings undergoing FDA review or minor editorial changes. (updated daily)
List of Products with Medication Guides
Safety Labeling Change Orders
Buying & Using Medicine Safely How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired drugs or medications you no longer use? How should you dispose of them?
Find the Latest Drug Product and Safety Information[ARCHIVED] An FDA Guide to Drug Safety Terms[ARCHIVED] Strengthening Drug Safety[ARCHIVED] Managing Drug Safety Issues[ARCHIVED]
Questions and Answers with Paul Seligman, M.D., M.P.H
Regulations and Guidance Documents
Federal food and drug regulations
CFR - Code of Federal Regulations Title 21
Postmarket Drug Safety Information for Patients and Providers: Selected Safety Regulations Search for FDA Guidance Documents
FDA Guidance Documents - Many guidances related to safety
CDER Guidances on Drug Safety
Drug Safety Information - FDA's Communication to the Public(PDF - 87KB)
- Guidance on Drug Safety Information--Food and Drug Administration's Communicatio
Guidance: Drug Safety Information - FDA's Communication to the Public; Availability - PDF [50.65 KB]