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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 Comments on Global Benchmark for Efficient…
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BIO Comments on Guarding U.S. Medicare Against…
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Letter From BIO President & CEO John F. Crowley…
Dear Mr. Thune, Mr. Schumer, Mr. Johnson, and Mr. Jeffries:As President and CEO of the Biotechnology Innovation Organization (BIO), as a father and entrepreneur whose family is here today because of biotech innovation, and on behalf of the more than…
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BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information
November 27, 2017
BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely…
BIO Comments to FDA on “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” (FDA-2017-N-5991; November 17, 2017)
November 21, 2017
Re: FDA-2017-N-5991: “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments”To whom it may concern:The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the…
BIO Comments on FDA Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity
November 21, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity. The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of…
Congressional Black Caucus and Congressional Hispanic Caucus Letter to EPA on RFS RVO
November 16, 2017
We are writing regarding the proposed 2018 Renewable Volume Obligation under the RFS. Rather than support continued growth in the lowest carbon types of biofuels under the statue, your proposal reduces the blending target for cellulosic biofuels and…
BIO Comments on Benefit-Risk Assessments in Drug Regulatory Decision-Making
November 13, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making. The benefit-risk framework is an important advancement in FDA product regulation because it reflects and…
BIO Submits Comments Re: HHS Draft Strategic Plan FY 2018-2022
November 9, 2017
BIO submitted comments in response to the Health and Human Services (HHS/the Agency) Draft Strategic Plan for Fiscal Years 2018-2022. BIO strongly supports HHS’ mission to enhance the health and well-being of Americans, by providing for effective…
BIO Submits Comments Re: USP Drug Classification System, Second Round of Public Comments
November 9, 2017
BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September…
Congressional Letter to FDA, USDA and EPA on Animal Biotechnology
October 17, 2017
BIO's Letter to the Senate Committee on Judiciary Regarding Deficiencies at the USPTO
October 12, 2017
BIO President and CEO James C. Greenwood details deficiencies at the USPTO that are undermining longstanding and carefully-balanced procedures governing market entry and patent dispute resolution under the highly successful Hatch…
BIO Comments on FDA Draft Guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products
October 10, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports. BIO appreciates the…