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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
CSBA Letter to Congressional Leaders on PBM, PPRV…
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
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BIO's Comments on Advisory Committee on…
Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee…
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Testimony of BIO President & CEO John F. Crowley…
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000…
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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…
BIO Sends Letter to House Committee on Climate Crisis on Building a Resilient Food Supply
May 24, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House of Representatives Select Committee on the Climate Crisis hearing entitled, “Climate Smart From Farm to Fork: Building…
BIO Comments on FDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
May 9, 2022
On Monday, May 9th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. In the comments submitted, BIO acknowledged the challenge FDA faces in creating a…
BIO Submits Comments to FTC on PBM Business Practices
May 5, 2022
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Federal Trade Commission’s (FTC’s or the Commission’s) Solicitation for Public Comments on the Business Practices of Pharmacy Benefit Managers and…