Understanding Regulatory Expectations for Post-Approval Changes in ANDAs
Wednesday, November 10, 2021
12:00 p.m. - 1:00 p.m.
Industry has to make decisions regarding the category of submission based on their understanding of the changes and has uncertainty in interpreting FDA’s current guidance documents. There are instances when the industry’s perspective does not match with that of the agency, which leads to complications and delays related to post-approval changes. There is a need for greater clarity from FDA on the types of changes that require a PAS, CBE or that can be reported in an Annual Report for an ANDA. This session will examine the types of changes that may be appropriate for each, what regulatory questions may be raised, and where additional guidance from FDA is needed. The session will also provide helpful hints and tips on how manufacturers can better manage changes to their process, sites and labels.
Moderator: Marcy Macdonald
Vice President, Regulatory, Tolmar
Kylie Grainger, PhD
Chemist, Division of Post Marketing Assessment II, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs, Apotex Corp.
Oluwakemi “Kemi” Odesina, PharmD, BCPS, CPH, RAC
Reviewer, Division of Labeling Review, Office of Regulatory Operations (ORO), OGD, CDER, FDA
Olugbenga (Benga) Okudabejo, PharmD
Division Director, Division of Regulatory and Business Process Management III, Office of Program and Regulatory Operations, OPQ, CDER, FDA
Vice President, North America Generics Regulatory Affairs, Teva Pharmaceuticals