April 25, 2024
Enroll in the Product-Specific Guidances Course
Enroll in the Facilitating Generic Drug Product Development through Product-Specific Guidances course to access all lessons and resources.
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Presentations
About This Course
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.
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
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- Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Draft Guidance (February 2023)