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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 Submits Comments on Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II
July 27, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on the statement of work for assessment of the Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee…
BIO comments to FDA Regarding the Regulation of Intentionally Altered Genomic DNA in Animals
June 20, 2017
BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on the draft guidance for industry (GFI) #187, entitled Regulation of Intentionally Altered Genomic DNA in Animals2…
BIO Comments to FDA on Genome Editing in New Plant Varieties Used for Foods
June 19, 2017
BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on genome editing in plants.
BIO Comments to USDA on its 340 Biotech Rules
June 19, 2017
BIO is pleased to submit these comments in response to the USDA Animal and Plant Health Inspection Service’s (APHIS’) request for public input on the proposed revisions to its biotechnology regulations in 7 CFR Part 340.
BIO IES: Advanced Biofuel RVP EPW Letter 170612
June 12, 2017
On behalf of the advanced and cellulosic biofuel industry and our respective companies and organizations, we are writing to ask for your support for the Consumer and Fuel Retailer Choice Act (S. 517), which is scheduled to be marked up in the…
BIO IES: Advanced Biofuel RVP EPW letter 170612
June 12, 2017
On behalf of the advanced and cellulosic biofuel industry and our respective companies and organizations, we are writing to ask for your support for the Consumer and Fuel Retailer Choice Act (S. 517), which is scheduled to be marked up in the…
Advanced Biofuel RVP EPW letter 170612
June 12, 2017
On behalf of the advanced and cellulosic biofuel industry and our respective companies and organizations, we are writing to ask for your support for the Consumer and Fuel Retailer Choice Act (S. 517), which is scheduled to be marked up in the…
US Biotech Alliance Sends Letter to USTR on Modernizing NAFTA
June 12, 2017
The U.S. Biotech Crops Alliance appreciates the opportunity to provide comments in response to USTR’s Request for Comments on negotiating objectives regarding modernization of the North American Free Trade Agreement with Canada and Mexico (82 FR…
BIO Submits Comments to FDA on Enhancing Patient Engagement Efforts
June 12, 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on Enhancing Patient Engagement Efforts Across the Food and Drug Administration.
BIO Comments to USTR on Modernizing NAFTA
June 12, 2017
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to respond to the U.S. Trade Representative’s (USTR) request for comments on negotiating objectives to modernize the North American Free Trade Agreement (NAFTA).