Facilitating Generic Drug Product Development through ProductSpecific Guidances

>> YOUR LINK HERE: ___ http://youtube.com/watch?v=tFlVvj3L-qQ

The purpose of this webinar was to provide current and prospective generic drug applicants insight on how PSGs are developed, revised, and published, and how PSGs may be used to improve the efficiency of generic drug development. • Timestamps • 05:08 – PSG Program: Updates and Overview of Available Resources • 30:03 – Beyond General Guidance: Tailored PSG Recommendations for Immediate Release Oral Drug Products • 45:15 – Development of Generic Drug Products Under Suitability Petition • 57:50 – Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs • 01:12:44 – Consideration Factors for Study Population Selection in Bioequivalence Studies with Pharmacokinetic Endpoints • 01:28:00 – FDA Dissolution Methods and Navigating the Dissolution Database • 01:38:14 – Panel Discussion • 02:16:50 – Speaker Q A Discussion Panel • 02:56:03 – Closing Remarks • Speakers | Panelists: • Joseph Kotsybar, Pharm.D. • Regulatory Health Project Manager • Office of Research and Standards (ORS) • Office of Generic Drugs (OGD) • CDER | FDA • Qi Zhang, Ph.D. • Lead Pharmacologist • Division of Therapeutic Performance II (DTP II) • ORS | OGD | CDER | FDA • Heather Boyce, Ph.D. • Lead Pharmacokineticist • DTP II | ORS | OGD | CDER | FDA • Karthika Natarajan, Ph.D. • Staff Fellow • DTP I | ORS | OGD | CDER | FDA • Jihong Shon, M.D., Ph.D. • Senior Staff Fellow • DTP II | ORS | OGD | CDER | FDA • Leah W. Falade, Ph.D. • Senior Pharmacologist • Office of Product Quality Assessment II (OPQA II) • Office of Pharmaceutical Quality (OPQ) • CDER | FDA • Robert Lionberger, Ph.D. • Director • ORS | OGD | CDER | FDA • Dave Coppersmith, J.D. • Regulatory Counsel • Division of Policy Development (DPD) • Office of Generic Drug Policy (OGDP) • OGD | CDER | FDA • Utpal Munshi, Ph.D. • Division Director • Division of Bioequivalence I (DBI) • Office of Bioequivalence (OB) • OGD | CDER | FDA • Markham Luke, M.D., Ph.D. • Division Director • DTP I | ORS | OGD | CDER | FDA • Myong-Jin Kim, Pharm. D. • Division Director • DTP II | ORS | OGD | CDER |FDA • Liang Zhao, Ph.D. • Division Director • Division of Quantitative Methods and Modeling (DQMM) • ORS | OGD | CDER | FDA • Lei Zhang, Ph.D. • Deputy Director • ORS | OGD | CDER | FDA • Learn more at: https://www.fda.gov/drugs/news-events... • ----------------------- • FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products clinical research. • Upcoming Training - https://www.fda.gov/cdersbia • SBIA Listserv - https://public.govdelivery.com/accoun... • SBIA 2022 Playlist - • 2022 CDER Small Business and Industry... • SBIA LinkedIn -  / cder-small-business-and-industry-assistance • SBIA Training Resources - https://www.fda.gov/cdersbialearn • Twitter -  / fda_drug_info • Email - [email protected] • Phone - (301) 796-6707 I (866) 405-5367

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