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
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.
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.