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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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Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
July 19, 2016
BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BIO recognizes that access to medically-needed…
BIO Comments on Renewable Fuel Standards for 2017
July 11, 2016
BIO urges EPA to get the RFS back on track with a commitment to stable implementation of the program that tracks statutory requirements. In particular, we urge EPA to account more appropriately for the availability of advanced and other biofuels to…
Combination Products: BIO Comments on FDA Draft Guidance Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development”
June 23, 2016
Re: Docket No. FDA-2015-D-4848: Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development   Dear Sir/Madam:   The Biotechnology Innovation Organization (BIO) thanks the Food…
Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products
June 23, 2016
Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016))   The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug…
CMC: BIO Submits Comments on FDA Draft Guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information
June 23, 2016
Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA)…
Office of the National Coordinator for Health Information Technology; Medicare Access and CHIP Reauthorization Act of 2015; Request for Information (RFI) Regarding Assessing Interoperability for MACRA
June 3, 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the Request for Information (RFI) Regarding Assessing Interoperability for MACRA (the “RFI”).1 BIO is the world's largest trade association…
BIO Letter to Senate Appropriations Leadership on Efforts to Label Foods Produced Through Biotechnology Such As the Genetically Engineered Salmon
May 19, 2016
The Biotechnology Innovation Organization (BIO) urges you and all members of the Senate Appropriations Committee to support a national bioengineered food labeling legislative solution, which Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI)…
BIO Submits Comments to FDA's Draft EA and Preliminary FONSI Regarding the Proposed Field Trial of the OX513A Strain of Aedes aegypti (Ae. aegypti)
May 18, 2016
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the U.S. Food and Drug Administration (FDA) on the draft environmental assessment (EA)1 and preliminary finding of no significant impact (FONSI)…
BIO Comments Re: Comments on Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors
May 17, 2016
Dear Dr. Taichman: The Biotechnology Innovation Organization (BIO) is pleased to offer the following comments on Sharing Clinical Trial Data: A proposal from the International Committee of Medical Journal Editors (“ICMJE”) (“the Proposal”). 1 BIO…
BIO Comments on FDA Natural Food Labeling
May 11, 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments to FDA in response to FDA’s request for information on the use of the term “natural” on food labeling (docket no. FDA-2014-N-1207). BIO is the world's largest…