As technology changes, so do the tools we use to combat disease in the United States. Many companies use new technologies and scientific innovations to develop new generations of drugs, medical devices, and biological products such as vaccines. Some of these new medical products hold great promise. But some pose great risk.
Part of the Food and Drug Administration’s (FDA) mission is to evaluate new therapies and determine which are safe and effective for their intended use. This is a complex job, often involving many areas of expertise, and sometimes FDA turns to outside experts for counsel.
The Food and Drug Administration (FDA) is informing consumers of—and protecting them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the 2009 H1N1 influenza virus.
Within the past two weeks, FDA has
urged caution regarding promotions and Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat or cure the H1N1 flu virus
enhanced efforts to warn about potentially deceptive H1N1 products, and...
FDA's advisory committees provide independent, expert advice to the agency on a range of complex scientific, technical, and policy issues. This includes questions related to the development and evaluation of products regulated by FDA. The agency currently has 48 technical and scientific advisory committees and panels. They are a valuable resource and make an important contribution to the agency’s decision-making processes. Although advisory committees provide recommendations to the agency, FDA makes the final decisions.
What is an FDA advisory committee?
An advisory committee lends credibility to the product review process and provides a forum for public discussion of certain controversial issues. The process helps air issues that do not have simple answers. For specific products, advisory committees consider the available evidence and provide scientific and medical advice on safety, effectiveness, and appropriate use. Committees might also advise the agency on broader regulatory and scientific issues.
Who serves on advisory committees and panels?
In general, each committee includes a chairperson, several members, a consumer representative, an industry representative, and often a patient representative. Additional experts may be added for specific meetings, as needed.
Committee membership typically includes ethnic, gender, and geographic diversity. Members have recognized expertise and judgment in a specific field. Typical members include
Experts in animal (preclinical) studies
Representatives for industry, patients, and consumers add different perspectives and expertise that give balance to the discussions and final recommendations.