Learning Tracks

This panel discussion will examine recent advances in the approval of complex generic drug products and the evolving regulatory science supporting future approvals. Speakers will share insights from both FDA and industry perspectives, with particular emphasis on: (i) FDA’s 2022 guidance Certain Ophthalmic Products: Policy Regarding Compliance with 21 CFR Part 4 and the Agency’s approach to applying Part 820 to ophthalmic combination products, including those with “lower-risk” device constituent parts; (ii) the regulatory distinction between locally-acting and systemically-absorbed nasal products, and its implications for nasal combination product development; and (iii) recommendations on determining what information is necessary for application submission and what will be expected during inspections.

Participants:
Poonam Chopra, PhD
Senior Scientist, DPQAVIII, OPQAII, OPQ, CDER, FDA

Kristi Lauritsen, PhD
Combination Products Regulatory Advisor and Product Jurisdiction Officer, CDER, FDA

Kirsten Ritter, PhD
Associate Director Regulatory Devices, Sandoz

Kimberly Witzmann, M.D.
Deputy Director, Office of Safety and Clinical Evaluation, OGD, CDER, FDA

Moderator: Michael Balon, BSc
Senior Director, Global Regulatory Affairs, Apotex Inc.