BIO Comments to FDA on “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence”
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)
Download Full Comments Below
BIO Comment Letter - FDA-2023-D-2318 - Substantial Evidence AWC
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)