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U.S. Department of Health and Human Services

Drugs

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Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting; Request for Comments

The Food and Drug Administration (FDA or the Agency) held a public meeting that provided an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested stakeholders––as it fulfills its statutory requirement under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public meeting into account in developing the FY 2014 Regulatory Science Plan.

Date:            June 21, 2013

Time:            9:00 a.m. to 5:00 p.m.

Location:     FDA White Oak Campus
                      10903 New Hampshire Avenue,
                      Bldg. 31, Room 1503 (Great Room)
                      Silver Spring, Maryland 2099

 

Webcast Information

A recording of the webcast can be found at the following (in 4 parts):

Transcript