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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 Commends the Introduction of the Helping Startups Continue to Grow Act
October 30, 2019
In a recent letter, BIO’s Jim Greenwood commended Representative Steil (R-WI) for introducing the “Helping Startups Continue to Grow Act,” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive…
BIO Testimony to the House Energy and Commerce Subcommittee on Environment and Climate Change: “Building a 100 Percent Clean Economy”
October 24, 2019
Thanks to biotechnology, advances in biofuels made from renewable resources and waste feedstocks can be used to decarbonize our roadways, seaways, and airways. In order to achieve the goal of a 100 Percent Clean Economy for this segment of the…
BIO Submits Comments to the Office of Science Technology and Policy (OSTP) on the Bioeconomy
October 22, 2019
The Biotechnology Innovation Organization (BIO) has submitted comments to the Office of Science Technology and Policy (OSTP) on the bioeconomy, explaining the critical role America’s biotechnology industry plays in feeding, fueling, and healing the…
BIO Submits Comments re: CY 2020 Medicare Physician Fee Schedule Proposed Rule
October 21, 2019
Dear Administrator Verma:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to commenton the Center for Medicare and Medicaid Services’ (CMS’s) CY2020 Revisions to PaymentPolicies under the Physician Fee Schedule (PFS) and…
BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule
October 21, 2019
Dear Administrator Verma,The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment onthe Centers for Medicare & Medicaid Services’ (CMS’) Medicare Hospital OutpatientProspective Payment and Ambulatory Surgical Center…
Pediatrics: BIO Comments on FDA Draft Guidance on Rare Pediatric Priority Review Vouchers
October 2, 2019
September 30, 2019Re: Docket No. FDA–2014-D-1461: FDA Draft Guidance, Rare Pediatric Priority Review Vouchers.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity…
ICH: BIO Comments on ICH E8(R1) General Considerations for Clinical Studies
September 30, 2019
September 30, 2019Re: Docket ID FDA-2019-D-3049: E8(R1) General Considerations for Clinical Studies; International Council for HarmonisationDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA)…
BIO Comments on FDA Draft Guidance on ICH E19 Optimization of Safety Data Collection
September 27, 2019
BIO submitted comments to the Food and Drug Administration (FDA) on E19 Optimisation of Safety Data Collection; International Council for Harmonisation. BIO welcomes this document on the optimization of safety data collection and supports the goal…
ICH: BIO Submits Comments on FDA Draft Guidance ICH M10 Bioanalytical Method Validation
September 25, 2019
September 25, 2019Re: FDA-2019-D-1469: M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft Guidance for IndustryDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration …
BIO Comments on ICER’s Value Assessment Framework for Transformative Therapies
September 6, 2019
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Institute for Clinical and Economic Review’s (ICER’s) solicitation for input on draft revisions to its Value Assessment Framework for the…