Requesting FDA Feedback on Combination Products

On 3 December 2020 the FDA Announced the Availability of the Final Guidance for Industry and FDA Staff.

The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /