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  4. Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
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Virtual | Virtual

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


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

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

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