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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
Comments of the Biotechnology Innovation…
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
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BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
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BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability
March 16, 2017
March 13, 2017Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20852Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of…
BIO Submits Comments to FDA on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
March 14, 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s revised draft Guidance for Industry “Mixing, Diluting, or Repackaging Biological Products Outside the Scope…
BIO Comments on FDA Draft Guidance on Multiple Endpoints in Clinical Trials
March 14, 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Multiple Endpoints in Clinical Trials” (Draft Guidance).
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…