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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
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 Statement on Vaccines and Autism
Phyllis Arthur, EVP, Health Policy and Programs, “Vaccines are one of the most important and effective innovations for the defense of public health. They have saved millions of lives and drastically reduced or eliminated deadly and debilitating…
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BIO's Comments to CDC’s Advisory Committee on…
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
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Clinical Development: BIO Comments on FDA Draft Guidance Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
March 27, 2020
March 18, 2020 FDA Docket No: FDA-2019-D-4964: FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Dear Sir/Madam: BIO thanks FDA for developing this additional guidance on…
Pediatrics: BIO Comments on FDA Draft Guidance Pediatric Study Plans for Oncology Drugs: Questions and Answers
March 27, 2020
March 15, 2020 Re: Docket No. FDA–2019-D-4752: FDA Draft Guidance, Pediatric Study Plans for Oncology Drugs: Questions and Answers BIO appreciates FDA’s efforts to develop a document that outlines questions and answers pertaining to Pediatric…
BIO Signs on to Multi-Industry Letter Supporting Critical Infrastructure in Wake of COVID-19 Outbreak
March 25, 2020
In the wake of the COVID-19 outbreak, the Biotechnology Innovation Organization (BIO) joins 111 industry groups across sectors in a letter to federal, state and local lawmakers supporting uniform definitions of "critical infrastructure" as outlined…
Sustainable Aviation Fuels (SAF) Tax Incentive Letter to Congress
March 19, 2020
BIO greatly appreciates efforts from Congress to mitigate the current economic crisis for employers, employees, and all our families. In recent days, we have been asked by several of your colleagues for policy ideas that could assist with…
BIO Comments on FDA’s Proposal on Importation of Prescription Drugs from Canada
March 11, 2020
The Biotechnology Innovation Organization (“BIO”) would like to submit the following comments regarding FDA’s recent proposal to implement aspects of the Canadian importation provisions of Section 804 of the Food Drug & Cosmetics Act (“FD&C…
Council of State Bioscience Associations Comments on FDA’s Proposal on Importation of Prescription Drugs from Canada
March 11, 2020
The Council of State Bioscience Associations (“CSBA”) appreciates the opportunity to submit the following comments regarding FDA’s recent proposal to implement aspects of the Canadian importation provisions of Section 804 of the Food Drug &…
BIO Submits Letter to Office of Management and Budget on Part 340
March 6, 2020
Each of the below signatories submitted comments to the United States Department of Agriculture on the June 6, 2019, proposed rule regarding the movement of certain genetically engineered (GE) organisms [Docket No. APHIS-2018-0034] (OMB RIN 0579…
BIO Testifies on Biobased Products to Address Plastic Waste
March 5, 2020
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Energy and Commerce Subcommittee on Environment and Climate Change hearing entitled, “Reduce,…
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. …