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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

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