FDA Overhauls Manual on Inter-Center Consultations for Combination Products

The FDA updated its manual on handling inter-center consultation requests between CDER, CBER and CDRH for combination product reviews.

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 recommendations by the Combination Products Coalition (CPC), a group of leading drug, device and biologics companies. The revisions became effective June 11.

In 2014, the CPC issued recommendations 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 coalition said the revisions would encourage innovation and “put combination product regulation on the right path.”