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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 Testimony on Restoring R&D Tax Deduction
Biotechnology Innovation Organization statement for the record to the U.S. House Committee on Small Business Subcommittee on Economic Growth, Tax, and Capital Access hearing on "American Ingenuity: Promoting Innovation Through the Tax Code…
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Testimony on Intellectual Property Protections in…
The global IP framework has enabled lifesaving innovation and provides a reliable legal foundation for companies to voluntarily license their IP to enhance research collaborations and provide timely, equitable global access to safe and effective…
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BIO Comments to FDA (Docket No. FDA-2023-N-0398)…
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
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BIO Comments to FDA (No. FDA–2022-D-2983) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
May 2, 2023
BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.
BIO Comments to FDA–2023-N-0487: Discussion Paper: Artificial Intelligence in Drug Manufacturing
May 1, 2023
In these comments to FDA, BIO supports FDA’s efforts to improve future guidance related to Artificial Intelligence in Drug Manufacturing and outlines recommendations for FDA’s review and further consideration.
BIO Statement for House Financial Services Subcommittee on Capital Markets Hearing: “A Roadmap for Growth: Reforms to Encourage Capital Formation and Investment Opportunities for All Americans”
April 23, 2023
BIO’s Chief Advocacy Officer Nick Shipley presents comments to the Committee as it considers reforms to encourage capital formation and investment opportunities for all Americans.
CSBA Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
April 14, 2023
The CSBA Board of Directors endorses BIO’s formal comments on the Medicare Drug Price Negotiation Program, which are appended to this letter.  
BIO Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
April 14, 2023
BIO comments on the initial guidance regarding the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 issued by CMS on March 15, 2023 (Initial Guidance)
BIO COMMENT LETTER OMB Race and Ethnicity OMB 2023
April 12, 2023
BIO provided detailed comments to the Office of Management and Budget (OMB) regarding the Initial Proposals For Updating OMB’s Race and Ethnicity Statistical Standards.
BIO Comments to FTC
March 31, 2023
BIO response to Federal Trade Commission request for comment on the agency's Guides for the Use of Environmental Marketing Claims (Green Guides)
CSBA Letter to Congressional Leaders urging for passage of S. 866, the American Innovation & Jobs Act of 2023 (March 28, 2023)
March 30, 2023
BIO Statement to the U.S. International Trade Commission on COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities
March 29, 2023
BIO Statement to the U.S. International Trade Commission (USITC) for its Investigation into the TRIPS
March 17, 2023