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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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Benefit-Risk: BIO Comments on Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan
May 31, 2018
May 31, 2018 Re: Docket No. FDA-2018-N-1010: Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug…
BIO Comments on FDA Draft Guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding
May 25, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Compounded drugs can serve an…
BIO Written Testimony for House Financial Services Hearing on Legislative Proposals to Help Fuel Capital and Growth on Main Street
May 23, 2018
Good morning Chairman Huizenga, Ranking Member Maloney, and Members of the Capital Markets, Securities, and Investment Subcommittee. My name is Brian Hahn, and I am the Chief Financial Officer of GlycoMimetics, Inc., a 48-employee public biotech…
BIO Leads Letter on Need for Biostimulants Regulatory Clarity in Farm Bill
May 9, 2018
On behalf of the U.S. Biostimulant Coalition (USBC), the Biological Products Industry Alliance (BPIA), the American Seed Trade Association (ASTA), the Biotechnology Innovation Organization (BIO), and the Humic Products Trade Association, we are…
BIO Submission to the China Section 301 Investigation - September 28, 2017
April 4, 2018
BIO submitted comments to the Office of the United States Trade Representative (USTR) and the inter-agency Section 301 Committee regarding the investigation, initiated on August 18, 2017, by USTR under section 302(b) of the Trade Act of…
BIO Comments on FDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act Products
March 27, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products. The Prescription Drug User Fee Act …
BIO Comments on Proposed Settlement Agreement Between EPA and Philadelphia Energy Solutions on RFS Obligations
March 26, 2018
BIO is greatly concerned by the Department of Justice's and Environmental Protection Agency's proposed Settlement Agreement to resolve a dispute about the PES Holdings' obligations under the Renewable Fuel Standard.
BIO Comments on FDA Draft Guidance on Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
March 22, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. BIO supports the FDA’s efforts to update and replace the 1997…
BIO Comments on Promoting the Use of Complex Innovative Designs in Clinical Trials
March 20, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials. BIO supports the development and launch of this initiative. BIO shares the FDA’s goals for the…
BIO Submits Comments to House Ways and Means on Expired Tax Provisions
March 14, 2018
BIO supports a seamless multi-year extension for the Second Generation Biofuel Producer Tax Credit; Special Depreciation Allowance for Second Generation Biofuel Plant Property; Biodiesel and Renewable Diesel Fuels Credit; and the …