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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 Testifies to House Agriculture Subcommittee on the Next Farm Bill
March 9, 2017
The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30…
Testimony of Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization
March 2, 2017
What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide…
BIO Submits Comments to EMA on Strategies to Identify and Mitigate Risks for First-In-Human and Early Clinical Trials with Investigational Medicinal Products
February 28, 2017
The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with…
BIO's Testimony in Opposition to Maryland's House Bill 666
February 27, 2017
Patrick Plues, BIO’s Vice President, State Government Affairs, testified before the Maryland House in opposition to House Bill 666, which would require biopharmaceutical manufacturers to disclose specific information on cost inputs for specific…
BIO Comments on EPA’s Renewables Enhancement and Growth Support (REGS) Proposed Rule
February 16, 2017
BIO supports EPA’s ongoing efforts to improve the efficiency and effectiveness of the federal Renewable Fuel Standard (“RFS”) program, which was created by Congress, with bipartisan support, in statutory provisions that President George W. Bush…
BIO Comments on FDA's Guidance on Consultation Procedures: Foods Derived from New Plant Varieties
February 9, 2017
February 9, 2017 The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register1 regarding…
BIO Comments on FDA's Review of Existing General Regulatory and Information Collection Requirements
February 5, 2017
February 5, 2017 The Food and Agriculture Section of the Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in…
BIO Comments on FDA Draft Guidance on ANDAs for Certain Highly Purified Synthetic Peptide Drug Products Referring to Listed Drugs of rDNA Origin
February 4, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin. BIO supports enhanced regulatory guidance on…
BIO Submits Comments on FDA proposed rule: Good Laboratory Practice for Nonclinical Laboratory Studies
January 30, 2017
RE: Docket No. FDA-2010-N-0548: The Biotechnology Innovation Organization (BIO) appreciates the opportunity to offer comments to Food and Drug Administration (FDA)’s “Good Laboratory Practice for Nonclinical Laboratory Studies.” 
BIO submits comments to Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
December 23, 2016
The Biotechnology Innovation Organization appreciates the opportunity to offer comments to the final rule Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule,…