Postmarket Drug Safety Information for Patients and Providers

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FDA/Center for Drug Evaluation and Research

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

Approved Professional, Patient Labeling, and Patient Package Inserts in Drugs@FDA
DailyMed 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.
List of Products with Medication Guides

Risk Evaluation and Mitigation Strategies (REMS)

List of REMS
Federal Register Notice: 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

Postmarket Study Requirements and Commitments Searchable database of CDER and CBER commitments.

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

The Memorandum

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.
CDER What's New web page Includes drug safety announcements from CDER and MedWatch.
Medical Product Safety Information from MedWatch
FDA Drug Safety Podcasts Provides emerging safety information about particular drugs in conjunction with the release of Public Health Advisories.
Drug Safety Newsletter This publication provides postmarket information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.
Quarterly Reports on Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
AERS Data Files Downloadable files of raw data extracted quarterly from the AERS database.

Reporting Problems to the FDA

MedWatch

Warnings and Recalls

Regulations and Guidance Documents

Code of Federal Regulations, Title 21 - Food and Drugs Many FDA regulations related directly or indirectly to safety

Selected Safety Regulations

FDA Guidance Documents Many guidances relate to safety

CDER Guidances on Drug Safety

Guidance: Drug Safety Information - FDA's Communication to the Public

Notice of Availability [TXT] [PDF]

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

PDF requires the free Adobe Acrobat Reader

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