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Session 2: Overview of Complex Generic Drug-Device Combination Product Regulation
Session Chair(s)
Lisa Bercu, JD
Regulatory Counsel, Office of Generic Drug Policy
FDA, United States
Roisin Wallace
Vice President, Head of Global Device Development and Operations
Viatris, Ireland
This session will explore what is a combination product under FDA regulations and how to determine a product’s classification if uncertain, review combination product regulations, and highlight recent guidances FDA has published on combination products. This session also will address FDA’s recommendations on how to assess the user interface of a generic drug-device combination product and will identify commonly issued deficiencies for combination products. Finally, intellectual property considerations when developing a combination product will be addressed.
Learning Objective : - Define what is a combination product and understand what steps to take if there is uncertainty
- Describe the regulatory requirements for combination products for approval
- Explain how to assess the user interface of a combination product submitted in an ANDA and identify commonly issued deficiencies
- Discuss intellectual property considerations when developing a combination product
Speaker(s)
The Combination Product Regulatory Framework: Products Addressed, Substantive Principles, and Procedural Considerations
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Combination Product Review Responsibilities and Overview of User Interface Assessment
Jennifer Hammer, MD
FDA, United States
Physician
Drug-Device Combination Products – Quality Considerations
Kimberly Peters, MS
FDA, United States
Biomedical Engineer/Senior Policy Advisor, OPPQ, OPQ, CDER
IP Considerations for Device Development of Complex Drug-Device Combination Products
Samir R. Patel, JD
Mylan, United States
Associate General Counsel, Global IP
Panel Discussion
Elizabeth Bielski, PhD
FDA, United States
Pharmacologist, DTP, ORS, OGD
Panel Discussion
Irene Z. Chan, PharmD
FDA, United States
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,
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