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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. 

Drug Labeling

Risk Evaluation and Mitigation Strategies (REMS)

  • List of REMS
  • Federal Register Notice: PDF document Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007.

Studies and Clinical Trials of Approved Products Required by FDA or Agreed to by the Application Holder

Registries and Clinical Trials

  • Clinicaltrial.gov Registry and Results Databank ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world.  These trials are designed primarily to evaluate the premarket efficacy and safety of drugs and biologics, as well as for new indications for products currently marketed.

Memorandum of Agreement Between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research

Latest Safety Information

Reporting Problems to the FDA

Warnings and Recalls

Regulations and Guidance Documents

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

Using Medicines Safely

Consumer Articles on Drug Safety

General Health Information

  • MedlinePlus 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

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Date created: October 15, 2008, updated December 5, 2008