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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 Leadership…
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John F. Crowley, President and CEO of the…
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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CSBA Letter to Congressional Leadership on Most…
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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. …
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…