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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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BIO Submits Comments Re: Medicare CY 2019 Part D Proposed Rule
January 25, 2018
BIO supports CMS’s efforts to make changes to the Medicare Advantage, Medicare Fee-for-Service and the Part D Prescription Drug Benefit Programs in a manner that improves overall healthcare quality, while not compromising access to the most…
BIO Submits Comments Re: ICER Proposed Revisions to its Value Framework for Treatments for Ultra-Rare Diseases
December 11, 2017
BIO appreciates the opportunity to comment on these proposed revisions. Patients living with rare diseases often experience significant unmet medical need due to the lack of knowledge about how these diseases are caused or inherited and their…
BIO Submits Comments on FDA Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document
December 11, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document. The draft guidance provides recommendations to applicants on drafting proposed Risk…
BIO Comments on Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration
December 7, 2017
BIO submitted comments on Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration (FDA). BIO is committed to promoting a regulatory environment that continues to support and incentivize the…
BIO Comments on "Considerations in Demonstrating Interchangeability with a Reference Product"
December 5, 2017
The Biotechnology Innovation Organization ("BIO") welcomes the opportunity to submit  comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued…
BIO Comments: Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access
December 5, 2017
Bio Comments on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (Docket No. FDA-2017-N-3615)
BIO Submits Comments Re: HHS Notice of Benefit and Payment Parameters for 2019
November 29, 2017
BIO submitted comments in response to the Department of Health and Human Services' Proposed Notice of Benefit and Payment Parameters for 2019. In its annual update of standards and requirements related to the exchanges and the health plans offered…
BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information
November 27, 2017
BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely…
BIO Comments to FDA on “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” (FDA-2017-N-5991; November 17, 2017)
November 21, 2017
Re: FDA-2017-N-5991: “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments”To whom it may concern:The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the…
BIO Comments on FDA Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity
November 21, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity. The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of…