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U.S. Department of Health and Human Services

For Industry

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Prescription Drug User Fee Act (PDUFA) Public Meeting November 14, 2005

The Food and Drug Administration (FDA) held a public meeting entitled "Prescription Drug User Fee Act (PDUFA): Public Meeting," on November 14, 2005, at the Natcher Conference Center, National Institutes of Health (NIH).

The purpose of the public meeting was to hear stakeholder views as FDA prepares to work on amended authorizing legislation for PDUFA. The authority for PDUFA expires in September 2007, and without further legislation, FDA would no longer be able to collect user fees for the prescription drug program. Resources critical to running the program would become unavailable to FDA. We are interested in hearing about people's experiences with and perceptions of PDUFA to date and what aspects of PDUFA should be changed or retained. The meeting format included presentations by FDA and a series of panels representing different stakeholder interest groups (such as patient advocates, consumers, industry, health professionals, and academic researchers). The meeting agenda and transcript are available on the FDA Web site. Please see the Federal Register (FR) notice [Text] [PDF 62 KB] for additional information about meeting content.

The FDA Web site has more information regarding the PDUFA program. The PDUFA White Paper (Nov. 10, 2005) [PDF 4.28 MB] provides data and information on the scope and current status of FDA's program to implement PDUFA, so as to inform public discussions regarding PDUFA reauthorization.

Organizations and individuals could submit comments to the docket until December 14, 2005. The comments can be viewed at the FDA Web site: http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2005-N-0099.

Contact Person

For further information, contact: Patricia A. Stewart, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 301-796-4735, FAX: 301-847-3540, email: Patricia.Stewart@fda.hhs.gov.