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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
John F. Crowley, President and CEO of the…
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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CSBA Letter to Congressional Leadership on Most…
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CSBA Letter to Congressional Leadership on…
The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory-based non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative…
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Letter Supporting Doug McKalip as USTR Ag Negotiator
July 7, 2022
A coalition of 96 food and agriculture organizations signed a letter supporting the nomination of Doug McKalip as the Chief Agricultural Negotiator at the Office of the U.S. Trade Representative. The letter to Senate Finance Committee leadership…
BIO Comments on APHIS Strategic Plan Framework
July 5, 2022
BIO Sends Letter to Senate Ag Committee Supporting Alexis Taylor to Serve as USDA Under Secretary for Trade and Foreign Agricultural Affairs
June 24, 2022
We write to express our support for the nomination of Oregon Department of Agriculture Director Alexis Taylor to serve as the U.S. Department of Agriculture’s Under Secretary for Trade and Foreign Agricultural Affairs. U.S. agricultural producers…
BIO Comments on FDA Quality Metrics Reporting Program
June 22, 2022
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by…
BIO Responds to OSTP's RFI on Sustainable Chemistry
June 17, 2022
The Biotechnology Innovation Organization (BIO) is pleased to offer comments in response to the Office of Science and Technology Policy (OSTP) request for information on sustainable chemistry. Specifically, we seek to inform the development of a…
BIO Sends Letter to Congressional Leaders on Need to Repeal Harmful R&D Amortization Provision
June 15, 2022
The Biotechnology Innovation Organization (BIO), BIO members and State affiliates urge immediate legislative action to repeal the harmful R&D amortization provision that went into effect earlier this year. The 2017 Tax Cuts and Jobs Act (TCJA)…
BIO Comments on FDA Guidance on Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials
June 12, 2022
On Monday, June 13th, BIO submitted comments in response to a recently published FDA draft guidance providing recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in clinical trials…
BIO Comments on FDA Guidance: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cells Products
June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on Chimeric antigen receptor (CAR) T cell products (i.e., human gene therapy products in which the T cell specificity is genetically modified to enable recognition…
BIO Comments on FDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing
June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells. Overall, BIO found the guidance to be a well-written resource…
BIO Comments on FDA Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies
June 7, 2022
On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted…