Registration Now Open: FY 2022 Generic Drug Science and Research Initiatives Public Workshop

This FREE public workshop will provide an overview of the status of current science and research initiatives for generic drugs

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . Registration Now Open: FY 2022 Generic Drug Science and Research Initiatives Public Workshop   Please join us for the FY 2022 Generic Drug Science and Research Initiatives Public Workshop Date: May 9-10, 2022 Time: 8:00 a.m. – 4:30 p.m. on day one, 8:00 a.m. – 5:00 p.m. on day two Register Now   This FREE public workshop will provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA will take the information it obtains from the public workshop into account in developing its future Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives.   We have many informative sessions planned on topics including: The Next Five Years of the GDUFA Research Program, Implementing Practical and Efficient Model-Integrated Bioequivalence Approaches, Excipient Effects Relevant to Generic Drug Products, The Global Nature of the Generic Drug Industry, Implementing GDUFA Science in Product Development and Abbreviated New Drug Applications, and Generic Drug-Device Combination Products.   Audience 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.   WE WANT TO HEAR FROM YOU FDA seeks ideas on generic drug research topics from industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the next five years of the GDUFA Science and Research Program. You may submit your ideas for potential topics for the FY 2023 GDUFA Science and Research Priorities by submitting a comment on the public docket:  FDA-2017-N-6644.   Note: This workshop will be held virtually via Zoom and may also include an on-site option on FDA's campus depending on applicable guidelines for in-person gatherings.   For more information about the workshop, visit:  FY 2022 Generic Drug Science and Research Initiatives Public Workshop    Register Now The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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