BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.
Featured Letters, Testimony, & Comments
BIO Signs Coalition Letter In Support of the…
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…
The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations.
BIO applauds USDA for taking a proactive approach and seeking…
July 31, 2020
Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information.
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the…
Undermining the RFS at a time when rural America is struggling economically, farmers are fighting to stay in business, and the biofuels industry has been impacted by furloughs and plant closures is unconscionable. We respectfully urge you to reject…
We urge you to direct the EPA to reject all calls to waive the RFS. The RFS is more important now than ever as farmers, the biofuel sector, and rural America struggle to remain operating amid the COVID-19 crisis.
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of…
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Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.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…
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…
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 …
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…
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…
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…
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…
