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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 Benefit-Risk Assessments in Drug Regulatory Decision-Making
November 13, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making. The benefit-risk framework is an important advancement in FDA product regulation because it reflects and…
BIO Submits Comments Re: HHS Draft Strategic Plan FY 2018-2022
November 9, 2017
BIO submitted comments in response to the Health and Human Services (HHS/the Agency) Draft Strategic Plan for Fiscal Years 2018-2022. BIO strongly supports HHS’ mission to enhance the health and well-being of Americans, by providing for effective…
BIO Submits Comments Re: USP Drug Classification System, Second Round of Public Comments
November 9, 2017
BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September…
Congressional Letter to FDA, USDA and EPA on Animal Biotechnology
October 17, 2017
BIO's Letter to the Senate Committee on Judiciary Regarding Deficiencies at the USPTO
October 12, 2017
BIO President and CEO James C. Greenwood details deficiencies at the USPTO that are undermining longstanding and carefully-balanced procedures governing market entry and patent dispute resolution under the highly successful Hatch…
BIO Comments on FDA Draft Guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products
October 10, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports. BIO appreciates the…
BIO Comments to USDA’s Office of Budget and Program Analysis on Identifying Regulatory Reform Initiatives, September 15, 2017
September 21, 2017
United States Department of Agriculture Jamie L. Whitten Building, Room 101-A 1400 Independence Ave SW Washington DC 20250 Re: Identifying Regulatory Reform Initiatives Dear Ms. Adcock: The Biotechnology Innovation Organization (BIO) is pleased…
BIO Submits Comments Re: Medicare CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B
September 20, 2017
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule regarding the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP). BIO…
BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule
September 20, 2017
BIO submitted comments on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Proposed Rule for calendar year (CY) 2018 (the …
SB 539 complaint
September 1, 2017