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Session 1: Generic Drug-Device Combination Products: Understanding the Regulatory Expectations for Drug-Device Combination Products Submitted in an ANDA
Session Chair(s)
Andrew A. LeBoeuf, JD, MS
, Neurocrine, United States
The session will provide a broad overview of the regulatory expectations for drug-device combination products submitted under an abbreviated new drug application (ANDA). Presenters will provide insight on the regulatory definition for combination products, outline the key regulatory considerations in seeking approval of a generic combination product, describe efforts underway to enhance inter-center communication and coordination of submissions, and an explanation of the associated cGMP and safety reporting requirements. Information on how ANDA applicants may interact with FDA during product development will also be included. The session will conclude with a panel discussion, intended to engage participants in the audience and on the panel.
Learning Objective : Understand regulatory definition of part 3 combination products
Speaker(s)
Introduction to CGMPs for Combination Products
Melissa Burns, MS
Senior Program Manager, Office of Combination Products, OCPP, OC, FDA, United States
Panelists
Brian McCormick
Vice President - Chief Regulatory Counsel, Teva Pharmaceuticals, United States
Combination Products 101
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA
Andrew A. LeBoeuf, JD, MS
, Neurocrine, United States
The GDUFA II Pre-ANDA Program
Kris Andre
Regulatory Affairs Advisor, Office of Generic Drug Policy, CDER, FDA, United States
Moderator
Martha Nguyen, JD
Director, Division of Policy Development, OGD, CDER, FDA, United States
Panelist
Andrew A. LeBoeuf, JD, MS
, Neurocrine, United States
Panelist
Alan Stevens, MS
Global Head, Complex Devices and Drug Delivery Systems, AbbVie, United States
Panelist
Kris Andre
Regulatory Affairs Advisor, Office of Generic Drug Policy, CDER, FDA, United States
Panelists
Melissa Burns, MS
Senior Program Manager, Office of Combination Products, OCPP, OC, FDA, United States
Panelists
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
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