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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
John F. Crowley's Annual Letter to BIO Membership
Dear Colleagues,  I am just past the two-year mark as BIO’s President & CEO, which arrives as we find ourselves at a defining moment for the future of biotechnology. For fifty years, our industry has delivered one of the great…
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BIO Comments on Global Benchmark for Efficient…
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BIO Comments on Guarding U.S. Medicare Against…
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Office of the National Coordinator for Health Information Technology; Medicare Access and CHIP Reauthorization Act of 2015; Request for Information (RFI) Regarding Assessing Interoperability for MACRA
June 3, 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the Request for Information (RFI) Regarding Assessing Interoperability for MACRA (the “RFI”).1 BIO is the world's largest trade association…
BIO Letter to Senate Appropriations Leadership on Efforts to Label Foods Produced Through Biotechnology Such As the Genetically Engineered Salmon
May 19, 2016
The Biotechnology Innovation Organization (BIO) urges you and all members of the Senate Appropriations Committee to support a national bioengineered food labeling legislative solution, which Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI)…
BIO Submits Comments to FDA's Draft EA and Preliminary FONSI Regarding the Proposed Field Trial of the OX513A Strain of Aedes aegypti (Ae. aegypti)
May 18, 2016
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the U.S. Food and Drug Administration (FDA) on the draft environmental assessment (EA)1 and preliminary finding of no significant impact (FONSI)…
BIO Comments Re: Comments on Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors
May 17, 2016
Dear Dr. Taichman: The Biotechnology Innovation Organization (BIO) is pleased to offer the following comments on Sharing Clinical Trial Data: A proposal from the International Committee of Medical Journal Editors (“ICMJE”) (“the Proposal”). 1 BIO…
BIO Comments on FDA Natural Food Labeling
May 11, 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments to FDA in response to FDA’s request for information on the use of the term “natural” on food labeling (docket no. FDA-2014-N-1207). BIO is the world's largest…
BIO Submits Comments Re: Medicare Program; Part B Drug Payment Model [CMS-1670-P]
May 9, 2016
The Biotechnology Innovation Organization appreciates this opportunity to submit comments on the Centers for Medicare and Medicaid Services’ proposed rule entitled Medicare Program; Part B Drug Payment Model...
Follow-Up on BIO’s Comments in Response to the ICER Value Framework
May 4, 2016
The Biotechnology Innovation Organization (BIO) would like to take the opportunity to follow-up and expand on the feedback we originally submitted to the Institute for Clinical and Economic Review (ICER) in October 2015 on the ICER Value Framework …
BIO letter in support of H.R. 5418
March 10, 2016
To establish a pilot program for educating district court judges on patent related issues.
Cures Acceleration Network: Legislative Text
March 10, 2016
The Cures Acceleration Network, passed in the recently enacted healthcare reform bill, will provide funding to public and private entities to bridge the gap between basic research and cures for patients.
Small Business Early Stage Investment Program: Legislative Text
March 10, 2016
The Small Business Early Stage Investment Program would provide matching funds for investment companies who invest in small, high tech companies, including biotech firm.