Back to Agenda
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
Associate Director Regulatory Policy, ONDP, OND, CDER
FDA, 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
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
Panelists
Brian McCormick
Teva Pharmaceuticals, United States
Vice President - Chief Regulatory Counsel
Combination Products 101
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
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
FDA, United States
Associate Director Regulatory Policy, ONDP, OND, CDER
The GDUFA II Pre-ANDA Program
Kris Andre
FDA, United States
Regulatory Affairs Advisor, Office of Generic Drug Policy, CDER
Moderator
Martha Nguyen, JD
FDA, United States
Director, Division of Policy Development, OGD, CDER
Panelist
Andrew A. LeBoeuf, JD, MS
FDA, United States
Associate Director Regulatory Policy, ONDP, OND, CDER
Panelist
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human
Panelist
Kris Andre
FDA, United States
Regulatory Affairs Advisor, Office of Generic Drug Policy, CDER
Panelists
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
Panelists
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Have an account?