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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
Testimony of John F. Crowley President and CEO,…
Chairman Griffith, Chairman Guthrie, Ranking Member DeGette, Ranking Member Pallone, and distinguished members of the subcommittee, thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO)…
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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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Clinical Outcomes and Endpoints: BIO Comments on Standard Core Sets: Clinical Outcome Assessments (COAs) and Endpoints Grant Program
January 10, 2020
January 4, 2020 Re: Docket No. FDA–2019-N-5157: 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program. Dear Sir/Madam: The Biotechnology Innovation Organization…
Select Committee on Climate Crisis: BIO Comments on Public Policies Needed to Help Biotech Address Climate Change
December 20, 2019
The Biotechnology Innovation Organization (BIO) is pleased to respond to the Select Committee's Request for Information (RFI) on how supportive public policy can help biotechnology reduce greenhouse gas emissions, enhance carbon sequestration,…
BIO Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions
December 17, 2019
On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro…
BIO Comments on CMS National Coverage Decision Memo for Advanced Cancer Next Generation Sequencing
December 17, 2019
On November 27, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Centers for Medicare and Medicaid Services’ (CMS’) National Coverage Determination for Diagnostic Laboratory Tests using Next Generation Sequencing (NGS)…
More than 135 Emerging Biotech Leaders Urge Congress to Reject H.R. 3
December 5, 2019
In a letter addressed to House Speaker Nancy Pelosi (D-CA) and House Republican Leader Kevin McCarthy (R-CA), 138 emerging biotech leaders warn that H.R. 3, the Lower Drug Cost Now Act, will “shatter the dreams” of patients and families who stand to…
BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction
November 18, 2019
Biotechnology Innovation Organization (BIO) comments on the FDA docket, Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO also believes that risks associated with opioid…
BIO Comments on Proposed Section 382(h) Regulations
November 13, 2019
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h).
BIO Comments on SEC Proposal to Amend the Accelerated Filer and Large Accelerated Filer Definitions
November 11, 2019
In a recent letter, BIO applauded the Securities and Exchange Commission (SEC) for taking a proactive approach in amending its accelerated and large accelerated filer definitions. “If adopted as proposed, these amendments will benefit startups and…
State Biotech Associations Warn Part D Redesign Puts New Treatments for Patients at Risk
November 4, 2019
In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for…
BIO Comments from Stephen Rapundalo (MichBio) on 2020 RFS SRE Public Hearing
October 31, 2019
October 30, 2019 Docket ID: No. EPA-HQ-OAR-2019-0136 Public Hearing: Renewable Fuel Standard Program: Standards for 2020 and Biomass Based Diesel Volume for 2021, and Response to the Remand of the 2016 Standards; Supplemental Notice of Proposed…