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  4. Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop - 05/20/2024
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Workshop | Mixed

Event Title
Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop
May 20 - 21, 2024

Date:
May 20 - 21, 2024
Day1:
Mon, May 20 8:00 a.m. - 04:30 p.m. ET
Day2:
Tue, May 21 8:00 a.m. - 04:30 p.m. ET

Location

In-Person at the FDA White Oak Campus
10903 New Hampshire Avenue, Building 31
Conference Center Room 1503, Sections B&C
Silver Spring, MD 20993.

Virtually via Zoom

About This Workshop

The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties, as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2025 Generic Drug User Fee Amendments (GDUFA) science and research priorities.

Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and regulatory assessment of generic products, including complex generics. Sessions of the FY 2024 GDUFA Public Workshop will facilitate public input on research needs for generic products, including those related to:

  • Nitrosamine Drug Substance-Related Impurities
  • Drug-Device Combination Products
  • Predictive Tools to Improve the Efficiency of Generic Product Development
  • Other Research Needed to Address GDUFA III Science & Research Priority Initiatives

Hybrid Options for Attendance

There is no cost to attend this public workshop. Registrants will have two options to attend: in-person or virtually. The workshop will be held on the FDA’s White Oak Campus. Seating is limited to approximately 250 attendees and will be available on a first come, first served basis. Attendees can indicate their interest to attend in-person during registration for this workshop and are encouraged to register early. Remote attendees may participate virtually via Zoom. For parking and security information, please refer to Visitor Information.

Members of the generic drug industry, scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs.

FDA Wants Your Input

FDA seeks ideas on generic drug research topics from the generic drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the FY 2025 science and research priorities for generic drugs. You may submit your ideas for potential topics for the FY 2025 GDUFA Science and Research Priorities by submitting a comment on the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of June 21, 2024.

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