Combination Products: FDA Updates Inter-Center Consult Request Manual

Regulatory NewsRegulatory News | 15 June 2018 |  By 

A staff manual detailing the US Food and Drug Administration's (FDA) internal policies and processes for handling inter-center consult requests (ICCR) for combination product reviews has been updated for the first time in 14 years to reflect changes to the process and feedback from external and internal surveys.
FDA says the manual is meant to describe the agency's policies for "when and how to request, receive, process, and track the progress" of ICCRs between its three review centers: the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH).
The manual is being updated to address issues identified in a 2014 survey conducted by the Combination Products Coalition (CPC), which recommended the agency "develop cross-Center policies for issues impacting combination product regulation (like usability testing), so the different groups are coordinated as much as possible in advance."
FDA later confirmed some of the findings from the CPC survey through an internal study in 2015.
In response, FDA piloted a new set of ICCR processes in August 2016.
According to FDA, the updated staff manual reflects the results of the pilot and requirements to ensure more timely and effective reviews for products involving more than one review center under the 21st Century Cures Act.


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