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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BIO Comments to CMS on the Proposed Rule Dealing with Medicare Drug Pricing

February 13, 2023

BIO’s comments on specific aspects of CMS’s Proposed Rule on Medicaid drug pricing are presented below.

Ag Biotech Alliance Response to Biotech RFI

February 5, 2023

ABA 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 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On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…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