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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BIO Comments on FDA Draft Guidance on Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition Resulting from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies
September 25, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for…
BIO Comments on Facilitating Competition and Innovation in the Biological Products Marketplace
September 21, 2018
BIO submitted comments for the Food and Drug Administration (FDA) public hearing on Facilitating Competition and Innovation in the Biological Products Marketplace, which took place on September 4, 2018. BIO remarked on the need to foster a robust,…
BIO/Coalition for Safe, Affordable Food letter for Senate and House Ag Committee leadership in support of biotech education provision
September 20, 2018
Dear Chairman Roberts, Chairman Conaway, Ranking Member Stabenow, and Ranking Member Peterson:As representatives of the U.S. food and agricultural value chain and members of the Coalition for Safe, Affordable Food (the Coalition), we write to…
Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format
September 14, 2018
Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and FormatDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration …
BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B
September 14, 2018
BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and…
BIO Comments on FDA Draft Guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
September 11, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. In the comments, BIO applauds the FDA’s initiative to advance the use of patient…
BIO Comments on RFS Standards for 2019 and Biomass-Based Diesel Volumes for 2020
August 17, 2018
The Biotechnology Innovation Organization (BIO) is pleased to provide comment on the U.S. Environmental Protection Agency’s (EPA’s) proposed rule on the Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020 …
BIO Submits Comments on FDA Draft Guidance: Limited Population Pathway for Antibacterial and Antifungal Drugs
August 14, 2018
Re: Docket No. FDA-2018-D-2032: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs …
BIO Comments on FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
August 3, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials. The draft guidance is an important step towards ensuring stakeholders…
BIO Led Coalition Letter in Support of Cellulosic Biofuel Technologies
July 31, 2018
As the U.S. Environmental Protection Agency (EPA) begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), we encourage the agency to take a renewed look at commercial-ready cellulosic biofuels.