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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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Governors Letter to President Trump on Animal Biotechnology
February 25, 2020
We the undersigned Governors would like to draw your attention to an important issue facing U.S. agriculture. Farmer access to new biotechnologies, such as gene editing, is critical to maintaining the security and stability of the rural economy and…
21st Century Cures: BIO Comments on FDA Draft Guidance Qualification Process for Drug Development Tools
February 14, 2020
Dear Sir/Madam:  The Biotechnology Innovation Organization (BIO) thanks to the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Qualification Process for Drug Development Tools. …
Pediatrics: BIO Comments on FDA Draft Guidance on Pediatric Studies of Molecularly Targeted Oncology Drugs
February 13, 2020
February 11, 2020 Re: Docket No. FDA–2019-D-4751: Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
Request to EPA for Analysis of Lifecycle Ethanol GHG Emissons
February 12, 2020
Dear Administrator McCarthy, We write to request that the Environmental Protection Agency (EPA) update its greenhouse gas life-cycle emissions analysis for corn ethanol to include consideration of the current state of the industry and the published…
PFDD: BIO Comments on FDA Guidance Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making
February 7, 2020
February 3, 2020 Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding FDA’s public workshop on Patient-Focused Drug Development…
BIO's 2020 Special 301 Submission
February 6, 2020
Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access…
BIO Joins Letters Supporting EPA Nominee Michael Regan
February 4, 2020
The undersigned national agricultural organizations wish to extend our support for the nomination of Michael Regan to serve as Administrator of the Environmental Protection Agency.  Read the letter below:
BIO Comments on SEC Proposed Proxy Amendments
February 3, 2020
In comments to the Securities and Exchange Commission (SEC), BIO applauds the SEC for taking a proactive approach in amending the exemptions from the proxy rules for proxy voting. If adopted, the proposal will significantly improve proxy firm…
Office of New Drugs: BIO Comments on Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs
January 10, 2020
January 7, 2020 Re: Docket No. FDA–2019-N-3453: Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
Clinical Outcomes and Endpoints: BIO Comments on Standard Core Sets: Clinical Outcome Assessments (COAs) and Endpoints Grant Program
January 10, 2020
January 4, 2020 Re: Docket No. FDA–2019-N-5157: 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program. Dear Sir/Madam: The Biotechnology Innovation Organization…