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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, 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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CSBA Letter to Congressional Leadership on…
The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory-based non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative…
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BIO Response to Biotech RFI
February 5, 2023
BIO has submitted comments to the Office of Science & Technology Policy on how regulations underpinning the Coordinated Framework for the Regulation of Biotechnology can better facilitate the use of biotechnology to stimulate the economy…
BIO comments to USTR on the Agency’s 2023 Special 301 Review, January 30, 2023
January 31, 2023
BIO Response to RFI: National Biotechnology & Biomanufacturing Initiative
January 23, 2023
BIO's response to the Office of Science & Technology Policy's Request for Information concerning the National Biotechnology & Biomanufacturing Initiative
BIO Submits Comments on FDA Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
January 3, 2023
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO Comments on FDA Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs
December 13, 2022
On Tuesday, December 13th, BIO submitted comments in response to a recent FDA discussion paper for stakeholders on distributed manufacturing (DM) and point-of-care (POC) manufacturing. In the comments submitted, BIO commended the FDA on its…
BIO/Stakeholder letter to the Senate Judiciary Committee in opposition to the “Pride in Patent Ownership Act” (S. 2774)
December 9, 2022
Letter to the U.S. Patent and Trademark Office offering recommendations to strengthen the Patent Trial and Appeal Board (PTAB) process
December 9, 2022
BIO Letter to the EEOC on Special Carve Outs
December 5, 2022
Notice of Availability and Request for Comment: Equal Employment Opportunity Commission (EEOC) Draft Strategic Plan 2022–2026
Coalition Letter in Support of McKalip & Taylor Nominations
November 29, 2022
A coalition of groups, including BIO and several of its member companies, wrote Senate leaders urging confirmation of Doug McKalip as Chief Agricultural Negotiator for USTR and Alexis Taylor as Under Secretary for Trade and Foreign Agricultural…
Letter from BIO, along with 150+ health-focused organizations, to congressional leaders urging passage of the PASTEUR Act
November 16, 2022