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  • Writer's pictureHFUX Research | Medical HF

HFUX Research Presenting at FDA CDER FY 2024 Generic Drug Science and Research Initiatives Public Workshop

We are extremely thrilled to announce that #HFUXResearch #founder and #ceo, Heidi Mehrzad, has been invited by #FDA #CDER to speak at this year’s FDA FY 2024 Generic Drug Science and Research Initiatives Public Workshop as part of FDA’s #initiative to #facilitate #public #input on #research #needs for #generic #drug #development to address GDUFA III science and research priorities initiatives.


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:

  • Session 1: Nitrosamine Drug Substance-Related Impurities

  • Session 2: Drug-Device Combination Products Predictive Tools to Improve the

Efficiency of Generic Product Development

  • Session 3 and 4: Other Research Needed to Address GDUFA III Science & Research Priority Initiatives


In Session 4 of the GDUFA workshop, #presentations will #focus on the #development of #generics and corresponding #drugdevice #combinationproducts and its #challenges associated with #Comparative #Use #Human #Factors #Studies.


Heidi’s presentation:


will #focus on #exploring #alternatives to #current #comparativeuse #humanfactors #studydesign and Non-Inferiority (NI) #statistical #model proposed in FDA’s January 2017 draft guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.”


Date: May 20 - 21, 2024

Day1: Mon, May 20 8:00 AM - 4:30 PM ET

Day2: Tue, May 21 8:00 AM - 4:30 PM ET


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.

-OR-

Virtually via Zoom


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.


Click here for more information about the workshop, including how to attend in-person or virtually.





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