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FDA Overhauls Manual on Inter-Center Consultations for Combination Products
Devices Regulatory Affairs
The FDA updated its manual on handling inter-center consultation requests between CDRH, CDER and CBER for combination product reviews.
The Combination Products Coalition, a group of leading drug, device and biologics companies, issued recommendations in 2014 for reforming combination product regulation to improve coordination among parties involved in combination product reviews, including sponsor communication and justifications for agency data requests.
The agency overhauled the manual, the first update in 14 years, to include changes made to the process and piloted in 2016 in response to the CPC’s recommendations. The revisions became effective June 11.