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  1. Drug Safety and Availability

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

Studies and Clinical Trials of Approved Products

Risk Evaluation and Mitigation Strategies (REMS)

Registries and Clinical Trials

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

General Health Information

  • MedlinePlus - Health Information from the National Library of Medicine

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

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 search tool over 110,000 labeling documents for prescription drugs (including biological products, vaccines, blood products, cellular and gene therapy products), over-the-counter drugs, homeopathic drugs, animal drugs, and other products.
  • FDALabel - FDA’s labeling search tool over 110,000 labeling documents. FDALabel and DailyMed have the same database but have different search functions and different displays of search results.
  • 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.
  • Prescription Drug Labeling Resources - provides nearly 150 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

Regulations and Guidance Documents

Resources For You

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