Learning Tracks

In this session, FDA will provide an overview of ANDA assessment cycle actions and major deficiency trends. FDA will share common deficiencies issued by assessment disciplines, areas to improve ANDA submission quality, and resources available to industry. Industry will present their experience on frequently received comments and changes in data requests and offer their perspectives on review consistency and their experiences with late-cycle IRs and CRs in generic drug applications.

Moderator: Alberto Rivalta 
Senior Director, Generics Regulatory Affairs, Teva Pharmaceuticals

Bhupesh Singh Bisht, MPharm
Director, Regulatory Affairs U.S., Apotex

Darby Kozak, PhD
Deputy Director, OGD, CDER, Food and Drug Administration

Anand Saxena, M.Sc. 
Director, Regulatory Affairs, Cipla LTD

CDR Geoffrey Wu, PhD, PMP, CPH
Acting Office Director, OPQA I, OPQ, CDER, Food and Drug Administration