BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.
Featured Letters, Testimony, & Comments
More than 135 Emerging Biotech Leaders Urge…
We represent the community of emerging biotechnology companies whose researchers and scientists strive daily to develop innovative life-changing therapies and cures for patients. We take pride that we are providing hope to patients and their families and changing the world through medical breakthroughs
BIO provided comments on the Centers for CMS’ National Coverage Determination for Diagnostic Laboratory Tests using NGS for Medicare Beneficiaries with Germline (Inherited) Cancer.
BIO's comments on the EPA’s administration of the of the Renewable Fuel Standard (RFS) program and how it has put the investments made by BIO Member companies at risk and threatens to prevent growth in advanced and cellulosic biofuels as the…
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…
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 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…
On behalf of the Biotechnology Innovation Organization (BIO), thank you for the opportunity to provide comments to the United States Department of Agriculture on its June 6, 2019 Proposed Rule regarding the movement of certain genetically engineered…
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FDA Docket No: FDA-2019-D-4964: FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products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Re: Docket No. FDA–2019-D-4752: FDA Draft Guidance, Pediatric Study Plans for Oncology Drugs: Questions and Answers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…
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments on LD 1698, HP 1213, An Act To Create Jobs and Slow Climate Change by Promoting the Production of Natural Resources Bioproducts. We strongly support the…
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…
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 &…
