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
Comments of the Biotechnology Innovation…
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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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)…
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…
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…
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...
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 …
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.
March 10, 2016
Comments are regarding conservation and stewardship requirements, matching payments, establishment costs and annual payments, disclosure of competitively sensitive information, invasiveness determination and review, consistency with existing FSA…
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.
March 10, 2016
To establish a pilot program for educating district court judges on patent related issues.