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Am J Gastroenterol. 2014 Oct;109(10):1508-12. doi: 10.1038/ajg.2014.85. Epub 2014 Jul 8.

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

Author information

1
Global Regulatory Affairs, Alcon Laboratories, Fort Worth, Texas, USA.
2
LLC, Cherry Hill, New Jersey, USA.
3
Charlottesville Medical Research, Charlottesville Gastroenterology Associates, Charlottesville, Virginia, USA.
4
Houston Methodist Hospital, Baylor College of Medicine, Houston, Texas, USA.
5
NorthShore University HealthSystem, Highland Park Hospital, Highland Park, Illinois, USA.

Abstract

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

PMID:
25001252
DOI:
10.1038/ajg.2014.85
[Indexed for MEDLINE]

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