Letters, Testimony & Comments

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. 

In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.

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.

BIO’s submission is in response to the USPTO’s Request for Comments (88 FR 9492, February 14, 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…

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…

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.

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.

BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.

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.