Postmarket Drug Safety Information for Patients and Providers

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

• Safety Labeling Change Orders
• Index to Drug-Specific Information
• Drug Safety Communications
• News and Events for Human Drugs
• MedWatch Safety Alerts for Human Medical Products
• FDA Drug Safety Podcasts
• Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
• Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
• Postmarketing Drug Safety Evaluations
• Drug Safety Labeling Changes (SLC) Database

Studies and Clinical Trials of Approved Products

• Postmarket Requirements and Commitments Search

Risk Evaluation and Mitigation Strategies (REMS)

• REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS)
• REMS Integration Initiative
• Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)
• Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS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
• Template for Proposed REMS and REMS Supporting Document for a REMS that includes Only a Medication Guide and Timetable for Submission of Assessments
• 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

Registries and Clinical Trials

• ClinicalTrials.gov

Information about FDA's Drug Safety Oversight Board (DSB)

• Drug Safety Oversight Board Members
• Drug Safety Oversight Board Meetings: Public Summaries

General Health Information

• MedlinePlus - Health Information from the National Library of Medicine

FDA's Response to the Institute of Medicine's 2006 Report

• The Future of Drug Safety - Promoting and Protecting the Health of the Public

Prescription Drug Labeling

• Drugs@FDA - includes information about drugs, including biological products, approved for human use in the United States (e.g., product information, regulatory history, most recent FDA-approved Prescribing Information and patient labeling, and reviews by FDA staff that evaluate the safety and effectiveness of the product).
• DailyMed - NIH’s labeling tool designed to search over 140,000 labeling documents for prescription drugs (including “small molecules”, therapeutic proteins, vaccines, blood products, cellular and gene therapy products), over-the-counter drugs, homeopathic drugs, animal drugs, and other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods).
• FDALabel - FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods). FDALabel and DailyMed have the same database but have different search functions and different displays of search results. For the similarities and differences between FDALabel and DailyMed see Slides 42-44 in the Prescription Drug Labeling Updates presentation.
• Medication Guides - Medication Guides are a type of FDA-approved patient labeling for drugs used primarily on an outpatient basis when the FDA determines that it is necessary for patient’s safe and effective use.
• FDA’s Labeling Resources for Human Prescription Drugs webpage with the associated webpages such as the Prescribing Information Resources webpage - provides labeling resources for the Prescribing Information, FDA-approved patient labeling, and/or carton and container labeling for human prescription drugs, including biological products

Consumer Information

• Buying and Using Medicines Safely
• How to Dispose of Unused Medicines

Regulations and Guidance Documents

• Federal food and drug regulations
• Search all FDA Guidances

Resources For You

• REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS)
• Notice: Drug and Biologics Safety Surveillance Best Practice Statement
• Guidance Outlines How FDA Communicates, Prioritizes Drug Safety Issues

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