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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.

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BIO Comment Letter AA Oncology FDA 2023
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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level. 
BIO’s submission is in response to the USPTO’s Request for Comments (88 FR 9492, February 14, 2023)