Learning Tracks

This panel discussion will explore the complex generic drug products FDA has approved and the regulatory science that can support further approvals, including topics related to immunogenicity (generic peptides and oligos), long-acting injectables, complex API characterization, and other scientific topics. Additionally, this session will cover developments related to complex generics, from both Agency and industry perspectives.

Participants:
Rakhi Jajoo, MPharm
Deputy General Manager, Regulatory Affairs, Amneal Pharmaceuticals

Darby Kozak, PhD
Deputy Director, OGD, CDER, FDA

Cameron Smith, PhD
Supervisory Pharmaceutical Scientist, Division of Product Quality Assessment IV, Office of Product Quality Assessment (OPQAI), OPQ, CDER, FDA

Deepali Vartak, PhD
Senior Manager, Formulation Development, R&D (United States), Pharmaceuticals, Fresenius Kabi USA

Xiaoming Xu, PhD
Director, Division of Pharmaceutical Quality Research V (DPQRV), OPQ, CDER, FDA

Moderator: Brandon Wood, B.Sc.,
Senior Director, Regulatory Affairs & Combination Products Liaison, Teva Pharmaceuticals