Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.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.
All Letters, Testimony & Comments
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May 30, 2023
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. 
May 26, 2023
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
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.
May 15, 2023
BIO’s submission is in response to the USPTO’s Request for Comments (88 FR 9492, February 14, 2023)
May 10, 2023
BIO’s comments focus on two areas that threaten patient access to innovative medicines in Medicare: (1) the anti-innovation policies enacted as part of the Inflation Reduction Act, and (2) government policies that that are blocking patient access to…
May 5, 2023
The Biotechnology Innovation Organization (BIO) and BIO members urge immediate legislative action to repeal the harmful R&D amortization provision that went into effect in 2022 and urge Congress to swiftly pass S. 866/H.R. 2673, also known as…
May 5, 2023
In this Post-hearing Supplementary Written Submission, BIO submits detailed comments to support the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.
May 5, 2023
In this Post-hearing Supplementary Written Submission, BIO submits a 500-word summary of our position on the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.
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.
May 1, 2023
In these comments to FDA, BIO supports FDA’s efforts to improve future guidance related to Artificial Intelligence in Drug Manufacturing and outlines recommendations for FDA’s review and further consideration.