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Update on Submission and GMP Expectations for Part 3 Combination Products
Session Chair(s)
Michael Folkendt, MS
Associate Director for Regulatory Affairs, OPRO, OPQ, CDER
FDA, United States
This session will provide an update on both the submission and GMP requirements for part 3 combinations products as well as the current review process. Speakers will be from the FDA Office of Combination Products, CDRH and CDER.
Learning Objective : Describe when a combination product is considered a part 3 combination product; Discuss the current GMP requirements for part 3 combination products; Describe the submission expectations for part 3 combination products.
Speaker(s)
Combination Products: Regulation and Guidance Updates
Patricia Love, MD, MBA
FDA, United States
Deputy Director, Office of Combination Products, OCPP, OC
Perspectives Regarding the Jan FR Notice on GMPs for Part 3 Combination Products and Practical Recommendations: Information Expected in the Submission and Where to Put it in the eCTD Application
Carl Fischer, PhD
FDA, United States
Chief, General Hospital Devices Branch, OC, CDRH
Regulatory Evolution of Device Development for Injectable Drug Delivery
Suzanne Kiani, MSc
MedImmune, United States
Associate Director, CMC Regulatory
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