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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 2016 Special 301 Submission
February 8, 2016
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the 2016 Special 301 Submission. 
BIO Comments on FDA voluntary labeling of GE salmon
January 26, 2016
Food and Drug Administration Docket No. FDA-2015-D-4272; Food Labeling; Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry.
Congressional Black Caucus Letter to EPA on RFS RVO
October 30, 2015
As you finalize the proposed rules under the Renewable Fuel Standard, we respectfully urge you to not reduce the biofuels volume requirements. The RFS program has helped the environment, our economy, and has increased our confidence in renewable…
BIO Submits Comments Re: FDA Rare Diseases Guidance
October 22, 2015
RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development Dear Sir/Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the…
Rare Diseases: BIO Comments on Complex Issues for Rare Diseases
March 9, 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the docket regarding “Complex Issues in Developing Drug and Biologics Products for Rare Diseases.” Comments are…
FDA, Rare Diseases, Orphan Drug Act: Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases
May 31, 2010
BIO’s final comments on Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases.