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Workshop

Event Title
FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop
May 01, 2019

Scheduled

FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop - 05/01/2019 - 05/01/2019


Date:
May 01, 2019
Time:
May 01, 2019
Location:
Event Location
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave

Silver Spring, MD 20993
United States


Organized By:

Background:

FDA will hold a public workshop 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 reauthorization of the Generic Drug User Fee Amendments (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2020 Regulatory Science Plan.
 
The workshop will be held on May 1, 2019, at the FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Great Room Sections B & C, Silver Spring, MD 20993.

FDA wants your input. You may submit ideas on generic drug research topics to be included on the FY 2020 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.

Workshop Recordings:

Presentations:

Session I: Implementation of FY 19 Generic Drug Research Priorities

Session II: New drug approvals that pose scientific challenges to generic product development

Session III: Considerations for Future Regulatory Science Initiatives

Public Comment Presentations

FR Notice: Fiscal Year 2019 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments