---

---

---

AGENDA

Visit CDER Small Business and Industry Assistance Page

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• Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Draft Guidance (February 2023)

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.