Sponsors Want Answers On Consequences Of Missing US FDA Trial Diversity Goals
No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.
You may also be interested in...
Lola Fashoyin-Aje, formerly associate director of the Oncology Center of Excellence, will become director of the CBER Office of Therapeutic Products’ Office of Clinical Evaluation.
In another attempt to address concerns about the new mandate, the director of the US FDA’s Center for Drug Evaluation and Research said the agency must balance its interest in trial diversity with the need to get treatments to patients as soon as possible.
New guidance is due in a few months that should answer questions about how the FDA will react if a sponsor does not reach its clinical trial diversity goals.