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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
BIO Statement on Vaccines and Autism
Phyllis Arthur, EVP, Health Policy and Programs, “Vaccines are one of the most important and effective innovations for the defense of public health. They have saved millions of lives and drastically reduced or eliminated deadly and debilitating…
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BIO's Comments to CDC’s Advisory Committee on…
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
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CSBA Letter to Congressional Leaders Supporting…
Dear Majority Leader Thune, Minority Leader Schumer, Speaker Johnson, and Minority Leader Jeffries:The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory based non-profit trade associations, each of…
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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BIO Comments on FDA Draft Guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.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.
Letter to Rep. Barbara Comstock in Support of SUCCESS Act of 2018
July 26, 2018
BIO sent the following letter to Representative Barbara Comstock following her introduction of H.R. 6390, the “Study of Underrepresented Classes Chasing Engineering and Science Success Act of 2018” or the SUCCESS Act  
BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs
July 16, 2018
First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making…
BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule
July 16, 2018
BIO’s comments on the Proposed Rule are focused on the following areas:  Proposed changes to the IPPS for coverage and payment of Chimeric Antigen Receptor T-cell (CAR T) Therapy and other Transformative Therapies;  Updates to the Medicare…