Requesting FDA Feedback on Combination Products Guidance for Industry and FDA Staff

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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 (generally the most efficient and effective approach), such as the pre-submission process used in CDRH and CBER and the formal meetings used in CDER and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.

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