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Session 6: Requests, Disputes, and Appeals: A Process Primer for Combination Product Applicants
Session Chair(s)
Nancy Stade, JD
Partner
Sidley Austin LLP, United States
Deciding how – and with whom – to interact with FDA when questions arise concerning the assignment, investigation, or pre-market review of a combination products can be complicated. The administrative processes of the medical product centers differ, and there are also administrative processes unique to combination products. This session will address regulatory and strategic considerations in interacting with FDA before and during the pre-market review of an application for a combination product.
Learning Objective : Upon completion of this session, the participant should be able to:- Answer the question “when is an RFD required?”
- Describe the role of OCP in an appeal of a combination product decision under 21 C.F.R. 10.75
- Describe the role of the Agency Ombudsman in disputes between applicants and FDA involving combination products
Speaker(s)
Requests, Disputes, and Appeals: A Process Primer for Combination Product Applicants
Nancy Stade, JD
Sidley Austin LLP, United States
Partner
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