BIO Comments to the FDA on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (Docket No. FDA–2023-D-0110)
May 25, 2023
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.
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
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.