Virtual | Virtual

Event Title

FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs

May 5, 2021

Scheduled

Date:: May 5, 2021

Presentation Title	Presenter(s)
Opening Remarks	Lei Zhang, Deputy Director, ORS/OGD
Overview of the FDA Product-Specific Guidance Program	CDR Christine Le, PSG Program Manager (Acting), ORS/OGD
Non-Complex Drug Products and Product-Specific Guidances	Myong-Jin Kim, Division Director (Acting), Division of Therapeutic Performance II (DTP II), ORS \| OGD
Product-Specific Guidances for Complex Generic Drugs	Markham Luke, Division Director, Division of Therapeutic Performance I (DTP I) \| ORS \| OGD
Product-Specific Guidance Fundamentals from a Clinical Perspective	Mitchell Frost, Deputy Division Director (Acting), Division of Therapeutic Performance II (DTP II), ORS \| OGD
Developing and Implementing Science-Based Standards in Bioequivalence Assessment	Paramjeet Kaur, Senior Reviewer, Office of Bioequivalence (OB) \| OGD
Bioequivalence Regulations and Product-Specific Guidances	David Coppersmith, Regulatory Counsel, Office of Generic Drug Policy (OGDP) \| OGD
Closing Remarks	Rob Lionberger, Director, Office of Research and Standards (ORS), Office of Generic Drugs, CDER \| US FDA
Panel Discussion on Product-Specific Guidances	Lei Zhang Christine Le MJ Kim Markham Luke Mitch Frost Paramjeet Kaur Dave Coppersmith Rob Lionberger Bing Li OB/OGD

Agenda

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FDA will provide an overview of Product-Specific Guidances (PSGs), including how they are developed and revised and their role in facilitating generic drug development and generic drug application review. FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development.

This webinar is being offered as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor.

Learning Objectives

Describe general principals of PSGs
Discuss the process of how PSGs are developed and revised
Describe how FDA communicates current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs through PSGs
Understand how PSGs and other pre-submission communications facilitate generic drug development and generic drug application assessment.

Intended Audience

Generic drug industry stakeholders including current and potential applicants who are interested in submitting an application for generic drug development.

FDA Resources

Product-Specific Guidances for Generic Drug Development (main page)
Product-Specific Guidances for Generic Drug Development (database)
Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
Guidance for Industry, Bioequivalence Recommendations for Specific Products (Jun. 2010)
Guidance for Industry, Referencing Approved Drug Products in ANDA Submissions (Oct. 2020)
Guidance for Industry, Controlled Correspondence Related to Generic Drug Development (Dec. 2020)
Guidance for Industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (Nov. 2020)
FDA Drug Competition Action Plan