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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 Submits Comments on Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule
March 20, 2019
On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely…
BIO Submits Comments on Medicare CY 2020 Part D Draft Call Letter
March 20, 2019
BIO supports CMS’ commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment,…
BIO Comments on FDA Draft Guidance on Biomarker Qualification: Evidentiary Framework
February 11, 2019
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Biomarker Qualification: Evidentiary Framework. The guidance provides industry and FDA staff with recommendations on considerations to address when developing a…
BIO Comments on FDA Framework for Real-World Evidence Program
February 5, 2019
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Framework for a Real-World Evidence Program. As required by the 21st Century Cures Act, FDA created this framework for evaluating the potential use of Real-World…
BIO's Comment on Advanced Notice of Proposed Rulemaking Regarding Review of Controls for Certain Emerging Technologies
January 17, 2019
BIO urges the Administration to fully assess the potential impact of export controls on biotechnologies on “the impact on the economy of the United States” and on the sustainability of the U.S.’s global leadership in biotechnology, and pursue them …
BIO Submits Comments on Priorities for United States - United Kingdom Trade Agreement
January 15, 2019
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to respond to the U.S. Trade Representative’s (USTR) request for comments on negotiating objectives for a United States (US) – United Kingdom (UK) Trade Agreement.
BIO's Comments on the Expanded CFIUS Review Pilot Program
January 15, 2019
Comment letter to Treasury on the CFIUS pilot program 
Advance Notice of Proposed Rulemaking: International Pricing Index Model for Medicare Part B Drugs
December 31, 2018
BIO strongly opposes the potential proposal detailed in the Advance Notice of Proposed Rulemaking (ANPRM) on the International Pricing Index (IPI) and calls for withdrawal of the IPI model in its entirety.
BIO Sends Letter to President Trump on U.S.-China Trade & Biotech
December 18, 2018
The following letter was sent to the President of the United States in response to talks between the U.S. and China related to trade. 
BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications
December 18, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff. BIO appreciates…