Learning Tracks

This session will provide an understanding of current data and outcomes related to the evaluation of the device constituent part of generic combination products and how this might shape future assessment approaches.  This session also will provide information on:

• GDUFA regulatory science data that support understanding of user interface differences that will likely lead to differences in use error rates or use success rates.
• Alternative approaches to Comparative Use Human Factors Studies for those differences that pose no or low risk of error rates.

Moderator: Chris Lamanna, PhD
Head Regulatory Devices, Sandoz

Sharon Ahluwalia, M.D.
Physician, Division of Clinical Review (DCR), OSCE, CDER, Food and Drug Administration

Andrew Clerman, M.D., PhD
Acting Lead Physician, Division of Therapeutic Performance I (DTP I), ORS, OGD, CDER, Food and Drug Administration

Aparna Dagar, PhD, RAC
Senior Director, Regulatory Affairs, Fresenius Kabi USA, LLC

Panelist: Melissa Mannion PharmD, JD
Senior Regulatory Counsel, Office of Generic Drug Policy (OGDP), OGD, CDER, Food and Drug Administration