Requesting FDA Feedback on Combination Products
Title:
Requesting FDA Feedback on Combination Products
https://www.gmp-compliance.org/files/guidemgr/Combo Product Feedback Guidance_FINAL_11.30.20 (1).pdf
Origin/Publisher:
FDA
Document Type:
Guidance
Content:
The purpose of this guidance is to discuss ways in which combination product sponsors1 can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics