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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
BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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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…
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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. 
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Dr. Michelle McMurry-Heath's Testimony to Senate Finance Committee on USMCA
July 27, 2021
Chairman Wyden, Ranking Member Crapo, Members of the Committee, my name is Dr. Michelle McMurry-Heath. I am the President and CEO of the Biotechnology Innovation Organization (BIO). I am honored to testify before you for today’s hearing,…
BIO Comments on Cures 2.0 Discussion Draft
July 22, 2021
The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30…
BIO Comments on International Council for Harmonisation Q12: Implementation Considerations for FDA-Regulated Products
July 21, 2021
BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of…
BIO Signs on to Letter in Support of Under Secretary for Farm Production and Conservation Robert Bonnie
July 20, 2021
We write to express our support for the nomination of Robert Bonnie to serve as the U.S. Department of Agriculture’s Under Secretary for Farm Production and Conservation. The Under Secretary position is critical in overseeing the administration of a…
BIO Submits Comments on FDA Manufacturing, Supply Chain, and Inspections Guidances & Report
July 16, 2021
On Wednesday, July 14th, BIO submitted comments on FDA’s Guidances: 1) Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance; 2) Updated Manufacturing, Supply…
BIO Joins Letter to Senate Supporting USDA Undersecretary Confirmation
July 16, 2021
We, the undersigned organizations, representing a broad and diverse group of the agriculture industry are pleased to support the consideration for Jenny Lester Moffitt, who currently serves as Undersecretary of the California Department of Food and…
BIO Letter to Angela Merkel on the Benefits of Biotech
July 15, 2021
As you prepare for Chancellor Merkel’s visit to Washington, we, the representatives of America’s biotechnology sector thought that you and your government might benefit from an update on all that our sector is doing globally to address the ongoing…
BIO Letter to USTR Ambassador Tai on Global Vaccine Distribution
June 30, 2021
We would like to provide you some updates on the U.S. and global biotechnology industry’s efforts to scale-up global vaccine production to address the global imbalance in access to COVID vaccines, and to request a close working relationship with…
BIO letter to HHS Secretary Xavier Becerra on the importance of funding R&D for COVID-19 therapeutics at Biomedical Advanced Research and Development Agency (BARDA).
June 25, 2021
The partnership between the biopharmaceutical industry and the U.S. Government is largely responsible for where we are with the COVID-19 pandemic today. In just 16 months from the declaration of the pandemic, cases have dramatically dropped as more…
A Declaration from Members of the World’s Biotechnology Sector On Global Access to COVID Vaccines & Treatments and the Role of Intellectual Property
June 24, 2021
The undersigned CEOs of global biotechnology companies and associations have a social responsibility to work with other stakeholders – healthcare providers, governments, multilateral organizations, and non-governmental donor organizations – to…