Learning Tracks

Regulatory Barriers to Post-Approval Changes for Complex Generic Drugs

Wednesday, November 9, 2022

1:30 p.m. - 3:00 p.m.

Greater clarity is needed on the types of changes that require a PAS vs. a CBE or Annual Report for complex dosage forms (e.g., transdermals, injectables, respiratory drugs, combination products, etc.). How can industry overcome common regulatory barriers to post-approval changes for complex generic drugs? This session will examine case studies of the types of changes that may be appropriate for each, what regulatory questions may be raised, and where additional guidance from FDA is needed.

Moderator: Giuseppe Randazzo
Vice President, Sciences and Regulatory Affairs, AAM

Michael Balon
Global Director, Global Regulatory Affairs New Product Development, Apotex Inc.

Darby Kozak, PhD 
Deputy Director, Division of Therapeutic Performance I, Office of Research and Standards (ORS), OGD, CDER, FDA

Paul Schwartz, PhD 
Director, Division of Post-Marketing Activities II, OLDP, OPQ, CDER, FDA

Audra Stinchcomb, PhD
Professor of Pharmaceutical Sciences, University of Maryland School of Pharmacy

Janet Vaughn
Vice President, North America Generic Regulatory Affairs, Teva Pharmaceuticals

Siva Vaithiyalingam, PhD
Vice President, Regulatory Affairs, Cipla LTD


Hongling Zhang, PhD 
Director, Division of Bioequivalence II, OB, OGD, CDER, FDA