Placeholder Banner

BIO Comments to FDA–2023-N-0487: Discussion Paper: Artificial Intelligence in Drug Manufacturing

May 1, 2023

In these comments to FDA, BIO supports FDA’s efforts to improve future guidance related to Artificial Intelligence in Drug Manufacturing and outlines recommendations for FDA’s review and further consideration.

Download Full Comments Below
BIO Comment Letter AI Drug Manufacturing FDA 2023 N 0487
Discover More
BIO provided general comments and recommended edits Re: FDA-2023-D-3031
BIO Board Vice Chair and CEO of Amicus Therapeutics testified that the drug price controls in the Inflation Reduction Act harm drug research and development.
BIO submitted general comments and proposed changes to FDA (Docket No. FDA-2023-D-0026)