Learning Tracks

FDA has been active on several fronts related to complex generics. This session will offer an insider view of what the Agency has been up to and some of the core components of its complex generics program, including:

• Leveraging pre-ANDA program in pre-market approval of complex generics
• Pre-market assessment for complex generics
• How the pre-ANDA programs under GDUFA II and GDUFA III have helped complex generic products under GDUFA II
• How pre-market assessment for complex generics can cover multiple complex dosage forms
• Unique challenges of complex generics post-approval
• New FDA initiatives to address issues with complex products

FDA also will touch on information on the regulatory expectations for generic combination products, the Agency’s regulatory science work with respect to these products, and common regulatory challenges. In addition, industry representatives will offer perspectives on re-evaluating requirements and standards for life cycle management of complex products based on experience gained so far.

Moderator: Brandon Wood, BSc
Director, Regulatory Affairs, Gx Steriles, Teva Pharmaceuticals

Robert Lionberger, PhD
Director, ORS, OGD, CDER, FDA

Brock Roughton, PhD
Branch Chief, Division of Liquid-Based Products II, Office of Lifecycle Drug Products (OLDP), OPQ, CDER, FDA

Gina Sirianni, MSc
Director, Global Regulatory Affairs Co-Development, Apotex Inc.

Kalpana Vanam, MBA 
Senior Vice President, Regulatory Affairs, Gx, Specialty and Biosimilar, Lupin Pharmaceuticals Inc.

 Panelists:

Bing Li, PhD
Associate Director for Sciences, OB, OGD, CDER, FDA

Sarah Michel, PhD
Professor of Pharmaceutical Sciences and Associate Dean for Graduate Programs, University of Maryland School of Pharmacy

Michael Spagnola, M.D.
Lead Physician, Division of Clinical Safety and Surveillance (DCSS), Office of Safety and Clinical Evaluation (OSCE), OGD, CDER, FDA