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.
To protect patient access to critical prescription drugs, BIO has identified Part D guardrails (both MA-PD and PDP) for consideration as CMS develops guidance to plans for CY2025 and beyond.
This bipartisan and bicameral legislation is aimed at boosting rare disease drug development to ensure that patients have access to innovative therapies.
BIO Joins the Ag Energy Coalition, 10 allied organizations and 61 companies on a letter to House leadership urging support for the Biorefinery, Renewable Chemical and Biobased Product Manufacturing Assistance program (9003 program) in the Farm Bill…
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.