Facilitating Generic Drug Product Development through Product-Specific Guidances April 25, 2024

Virtual | Virtual

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• Date: April 25, 2024
• Time: 1:00 PM - 4:00 PM ET

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Topics & Presentations	Speakers
Facilitating Generic Drug Product Development through Product-Specific Guidances
PSG Program: Updates and Overview of Available Resources	Joseph Kotsybar, Pharm.D. Regulatory Health Project Manager Office of Research and Standards (ORS) Office of Generic Drugs (OGD) CDER | FDA
Beyond General Guidance: Tailored PSG Recommendations for Immediate Release Oral Drug Products	Qi Zhang, Ph.D. Lead Pharmacologist Division of Therapeutic Performance II (DTP II) ORS | OGD | CDER | FDA
Development of Generic Drug Products Under Suitability Petition	Heather Boyce, Ph.D. Lead Pharmacokineticist DTP II | ORS | OGD | CDER | FDA
Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs	Karthika Natarajan, Ph.D. Staff Fellow DTP I | ORS | OGD | CDER | FDA
Consideration Factors for Study Population Selection in Bioequivalence Studies with Pharmacokinetic Endpoints	Jihong Shon, M.D., Ph.D. Senior Staff Fellow DTP II | ORS | OGD | CDER | FDA
FDA Dissolution Methods and Navigating the Dissolution Database	Leah W. Falade, Ph.D. Senior Pharmacologist Office of Product Quality Assessment II (OPQA II) Office of Pharmaceutical Quality (OPQ) CDER | FDA
Panel Discussion	Joseph Kotsybar, Leah W. Falade, and 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
Speaker Q&A Discussion Panel	Joseph Kotsybar, Qi Zhang, Heather Boyce, Karthika Natarajan, Jihong Shon, and Leah W. Falade
Closing Remarks	Robert Lionberger, Ph.D. Director ORS | OGD | CDER | FDA

AGENDA

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ABOUT THIS EVENT

FDA’s Office of Generic Drugs (OGD) publishes product-specific guidances (PSGs), which describe the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to reference listed drugs.

The purpose of this webinar is 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. FDA publishes PSGs to give applicants seeking to develop generic drugs a better opportunity to efficiently allocate resources and clarity of FDA's expectations on the evidence needed to support an abbreviated new drug application (ANDA) approval, and ultimately promote generic drug product availability.

The event will include a panel discussion on topics pertinent to PSGs and a live Q&A session with FDA .

INTENDED AUDIENCE

• Members of the generic drug industry, including current and prospective applicants who are interested in submitting an ANDA
• Regulatory reviewers for generic drug assessments
• Consultants focused on bioequivalence
• Clinical research coordinators

TOPICS COVERED

• General Principles of PSGs
• PSG Lifecycle Overview
• Utility of PSGs
• Updates on PSG Program

AGENDA

FDA RESOURCES

• FDA Product-Specific Guidances
• Upcoming Product-Specific Guidances for Generic Drug Product Development
• Product-Specific Guidance Snapshot
• Bioequivalence Recommendations for Specific Products Final Guidance (June 2010)
• Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Draft Guidance (February 2023)