FDA Fact Sheet
January 30, 2007 |
FDA Press Office
301-827-6242 |
FDA's Commitment to Drug Safety
The safety of drugs and other medical products regulated by the U.S.
Food and Drug Administration (FDA) has always been, and continues to be,
a key focus of FDA's programs. This issue is of vital importance to the health
of the United States public and to the mission of FDA.
- FDA is committed to having a state-of-the-art drug safety system.
- Emerging science and technology are driving a transformation of all aspects
of medicine including drug safety.
- FDA is keeping pace with this transformation through a series of changes
and improvements to its drug safety system.
THE AGENCY WILL ACCOMPLISH THIS TRANSFORMATION BY:
- Strengthening the science that
supports the medical product safety system.
- Improving communication and information flow among all key stakeholders.
- Improving operations and management.
KEY HIGHLIGHTS INCLUDED IN TODAY'S ANNOUNCEMENT:
- New Advisory Committee on Risk Communications.
- Making specific organizational and management changes to increase communications
among FDA review staff and safety staff.
- New pilot program to assess the utility of postmarketing evaluations for
routine new molecular entities (NMEs).
- Recently signed agreement between FDA and the Veterans Health Administration
to share information and expertise on the use of FDA-regulated medical products.
- Implementation of a Center-wide electronic safety tracking system to ensure
a consistent approach across the Center for Drug Evaluation and Research
(CDER).
- Recent upgrade of AERS II, the second release of the Adverse Events Reporting
System database, a Web-accessible computer system, to add signal detection
and tracking tools.
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