Placeholder Banner

BIO Comments to FDA on Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials (FDA-2022-D-2629)

October 10, 2023

In response to their request for information, BIO submitted these comments, including line-by-line recommended edits.

Download Full Comments Below
Discover More
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.
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…