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BIO Comments to FDA (No. FDA–2022-D-2983) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products

May 2, 2023

BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.

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BIO Comment Letter Consideratins Externally Controlled Trials FDA 2022
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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.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 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.