The Food and Drug Administration (FDA or the Agency) will hold a public meeting that provides an overview of the current status of the regulatory science initiatives for generic drugs and there will be 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 2015 Regulatory Science Plan.

Date:            May 16, 2014

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

• Federal Register Notice
• Agenda (PDF - 59KB)
• List of Panelists (PDF - 35KB)
• Meeting Presentations
• Webcast (links below)
  • https://collaboration.fda.gov/p1yw9e0ecmg/
  • https://collaboration.fda.gov/p2lkyl1ud79/
  • https://collaboration.fda.gov/p818zvtq201/
  • Audio File (Contains additional presentations inadvertently omitted from webcast recording)
  • https://collaboration.fda.gov/p45l6s6lh1j/