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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
Comments of the Biotechnology Innovation…
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
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BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
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BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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Combination Products: BIO Comments on FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products
April 17, 2020
April 12, 2020   Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.   Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug…
BIO Signs on to Letter Urging Federal Government to Protect Essential Workers
April 14, 2020
We support prioritizing the healthcare sector for COVID-19 testing supplies, and as testing becomes more available and abundant, the undersigned organizations urge the federal government to provide COVID-19 testing resources to U.S. employers that…
Letter Urging USDA to Include Biofuels in COVID-19 Economic Relief
April 9, 2020
Given the impact the economic downturn has had on all biofuel technologies, we request that USDA ensures all advanced and cellulosic biofuels are eligible to receive assistance from the additional funds provided to the Commodity Credit Corporation …
BIO Letter to White House on Need for Animal Biotech Reform in Wake of COVID-19
April 7, 2020
As part of the Administration’s comprehensive response to the unprecedented health and economic impacts from the COVID-19 pandemic, the Biotechnology Innovation Organization (BIO) respectfully requests that the U.S. government immediately reform its…
Joint Letter to USTR on Need to Address Mexico's Delays of Ag Biotech Approvals
March 31, 2020
The undersigned organizations greatly appreciate your support for agricultural biotechnology in trade negotiations and other bilateral and multilateral engagements. Biotechnology is delivering valuable tools that help farmers increase productivity,…
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…