Learning Tracks

FDA recently issued a draft guidance to mitigate the workload and unnecessary delays experienced by the generic industry in developing parenteral, otic, and ophthalmic drugs. Meeting the requirements for qualitative and quantitative (Q1/Q2) sameness with respect to pH adjusters poses many challenges to the generic drug industry. This session will explore FDA’s plans for pH adjusters and Q1/Q2 assessments and provide industry perspectives on how differences to pH adjusters through a waiver under 21 CFR 314.99(b) demonstrate could help improve the efficiency of generic drug development and expand access to safe and effective generic medicines.

Moderator: Molly Ventrelli
Senior Vice President, Regulatory Affairs, Fresenius Kabi USA

Speakers:
Hee Sun Chung, PhD
Lead Pharmacologist, Division of Bioequivalence I (DBI), OB, OGD, CDER, FDA

Melissa Mannion, PharmD, JD
Regulatory Counsel, Division of Policy Development, Office of Generic Drug Policy (OGDP), OGD, CDER, FDA

Patricia Onyimba, MS
Branch Chief, Division of Liquid Based Products, OLDP, OPQ, CDER, FDA

Martin Shimer II, RPh
Executive Director, Regulatory Affairs, Lachman Consultant Services, Inc.

Chaoju Xiao
Director Formulation Development, Fresenius Kabi USA

Panelists:
Darby Kozak, PhD
Deputy Director, Division of Therapeutic Performance I, Office of Research and Standards (ORS), OGD, CDER, FDA

Utpal Munshi, PhD 
Director, Division of Bioequivalence I, OB, OGD, CDER, FDA

LCDR Truong-Vinh (Vinh) Phung, PharmD
Supervisory Pharmacist, Division of Filing Review (DFR), ORO, OGD, CDER, FDA