Combination Products & Similarity
Tuesday, November 9, 2021
12:00 p.m. - 1:30 p.m.
This session will explore device considerations when comparing generic combination products with the RLD and what qualitative and quantitative methods could be used for assessing the comparability of generic drug-device combination products. This session will also explore current thinking with respect to device related considerations for biosimilars.
Moderator: Markham Luke, M.D., PhD
Director, Division of Therapeutic Performance I, ORS, OGD, CDER, FDA
Program Manager, Co-Development, Apotex Inc.
Sarah Yim, M.D.
Director, OTBB, OND, CDER, FDA
CAPT Irene Chan, PharmD, BCPS
Acting Director, Division of Medication Error Prevention and Analysis 1, Office of Medication Error Prevention and Risk Management (OMEPRM), OSE, CDER, FDA
Dhaval Gaglani, MS
Branch Chief, Division of Immediate and Modified Release Products III, Office of Lifecycle Drug Products, OPQ, CDER, FDA