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FY 2016 Regulatory Science Initiatives Part 15 Public Meeting

The Food and Drug Administration (FDA or the Agency) will hold a public meeting that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties––as it fulfills its commitment 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 fiscal year (FY) 2017 Regulatory Science Plan.

FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the FY 2017 Regulatory Science Plan.

Submit electronic or written requests to make oral presentations and comments no later than April 29, 2016. Electronic or written comments will be accepted at any time until the docket closes on June 17, 2016. You may also submit ideas on generic drug research topics to be included on the FY 2017 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.

If you wish to attend, either in person or via webcast, or present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov by April 29, 2016. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number, and whether you will be attending in person or by webcast).

Information on other public meetings can be found on the GDUFA Regulatory Science website (see "Part 15 Public Meetings").  

Date: 
May 20, 2016

Time: 
9:00 a.m. to 5:00 p.m.

Location: 
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (Great Room)
Silver Spring, Maryland 20993

Meeting Materials

Federal Register Notice
Agenda (PDF - 76 KB)
Panel Members (PDF - 37 KB)
Meeting Presentations
 

Webcast Links

GDUFA Meeting Final Transcript