FDA's Drug Safety Initiative

The Food and Drug Administration (FDA) is aggressively improving the management of important drug safety issues. Safety has been, and continues to be, a central focus of our regulatory work. This Drug Safety Initiative includes:

Communication with the Public

• Index to Drug-Specific Information  For patients, consumers, and healthcare professionals. Provides links to safety sheets with the latest risk information about the drug, related press announcements, and other fact sheets.
  
  
• Consumer Education: What You Need to Know to Use Medicine Safely  Information to help patients and consumers work with health professionals to make the best medicine choices, buy safely, and use medicine so it's as safe and effective as possible.
  
  
• FDA Drug Safety Podcasts Provide emerging safety information about drugs in conjunction with the release of Public Health Advisories.
  
  
• Drug Safety Newsletter This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.
   
• Guidance: Drug Safety Information - FDA's Communication to the Public (Issued and Posted 3/2/2007)
  • Notice of Availability [TXT] [PDF]

Creation of the Drug Safety Oversight Board

• Manual of Policies and Procedures (MaPP): Drug Safety Oversight Board (DSB) (Updated and Posted 3/2/2007)
  
• Drug Safety Oversight Board Members
  
• Drug Safety Oversight Board Meetings: Public Summaries
  

Creation of the Drug Safety Oversight Board

• Manual of Policies and Procedures (MaPP): Drug Safety Oversight Board (DSB) (Updated and Posted 3/2/2007)
  
• Drug Safety Oversight Board Members
  
• Drug Safety Oversight Board Meetings: Public Summaries
  

More Information on the Drug Safety Initiative

Consumer Articles on Drug Safety

• Find the Latest Drug Product and Safety Information
• A Guide to Drug Safety Terms at FDA
• Spotlight On...Strengthening Drug Safety
• Consumer Update: Managing Drug Safety Issues - Questions and Answers with Paul Seligman, M.D., M.P.H
• Keeping Up With Drug Safety Information," May, 2006 article from FDA Consumer magazine

Fact Sheet and Press Releases

• FDA Drug Safety Initiative Fact Sheet
  
• Secretary Leavitt's February 2005 Press Release: FDA Improvements in Drug Safety Monitoring
  
• Statement by Steven Galson, CDER Director, Regarding The Institute of Medicine's "Future of Drug Safety" Report (9/26/2006)
  

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

• FDA News: FDA Reinforces Commitment to Drug Safety
  
• The Future of Drug Safety The Future of Drug Safety — Promoting and Protecting the Health of the Public
  

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Date created: May 5, 2005, updated September 11, 2008

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