BIO Comments to FDA on Enhancing Adoption of Innovative Clinical Trial Approaches (FDA-2023-N-4489)
January 19, 2024
In advance of the Agency's public workshop on Enhancing Adoption of Innovative Clinical Trial Approaches, BIO outlined specific considerations and plans to participate in the workshop.
Download Full Comments Below
BIO Comment Letter - Enhancing Adoption of Innovative Clinical Trial Approaches; Public Workshop
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.
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
In advance of the Agency's public workshop on Enhancing Adoption of Innovative Clinical Trial Approaches, BIO outlined specific considerations and plans to participate in the workshop.