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Session 4: Considerations for Development and Regulatory Review for Injection Devices
Session Chair(s)
Sarah Mollo, PhD, RAC, PhD, RAC
Combination Product Policy Analyst, OPEQ, CDRH
FDA, United States
Rosario LoBrutto, PhD
Executive Director, Head of Scientific Affairs
Sandoz, United States
ANDAs present unique review considerations as compared to NDAs for BLAs. The combination product in an ANDA needs to both meet the needs of a user as well as meet the requirements for a generic drug product. This session will provide an FDA perspective on the expectations and common pitfalls of two key areas of an ANDA; the drug product quality review and device performance review. Additionally, industry representatives who have developed and marketed combination products for an ANDA will highlight some of the current advances in this space as well as some of the challenges they have encountered.
Learning Objective : - Apply lessons learned from case studies during the development of injectable primary pack (e.g. PFS, pen injector, auto injector) technologies
- Identify drug product quality and device performance expectations for a generic application for products including injection devices
- Proactively identify potential issues that could be encountered during review of a generic application with injection devices
Speaker(s)
Quality Assessment of Generic Combination Parenteral Drug Products
Farnoosh Fazlollahi, PhD
FDA, United States
Product Quality Assessor, FDA-CDER-OPQ-OLDP
Current Advances in Ready to Use/Ready to Administer Products
Paolo Mangiagalli, PhD
Sanofi, France
Senior Director, Device Development Unit
Challenges and Consideration in Auto Injector Development for Generic Combination Products
Mark DeStefano
Teva Pharmaceuticals, United States
Director: Combination Products and Device R&D
Evolving Component Technologies to Meet the Needs of Cartridge Delivery Applications
Royce Brockett, MBA
West Pharmaceuticals, United States
Director of Product Management, Prefilled Systems and Delivery
Device Performance Considerations for Injection Devices
Rumi Young, MS
FDA, United States
Acting Team Lead, Combination Products
Panelist
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human
Panelist
Irene Z. Chan, PharmD
FDA, United States
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,
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