Letters, Testimony and Comments
CSBA Letter to Congressional Leaders urging for passage of S. 866, the American Innovation & Jobs Act of 2023 (March 28, 2023)
March 30, 2023
Download Full Comments Below
BIO Comments to FDA (Docket No. FDA-2023-N-0398)…
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
Letter in support of U.S. Codex Office funding
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 Comments to the FDA on Clinical Trial…
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.