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 Letter to Congressional Leadership on the…

One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…

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John F. Crowley's One-Year Anniversary Letter to…

Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…

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BIO Comments on Office of Management and Budget …

Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…

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BIO Statement to the U.S. International Trade Commission on COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities

March 29, 2023

CSBA letter to USITC Expressing Concerns with Proposed WTO TRIPS Waiver Expansion

March 17, 2023

BIO Statement to the U.S. International Trade Commission (USITC) for its Investigation into the TRIPS

March 17, 2023

Ag Value Chain Letter to President Biden on Technical Consultations with Mexico on Corn

March 9, 2023

As organizations representing America’s highly innovative and competitive food and agricultural value chain, we write to express our thanks for USTR’s announcement that it will begin technical consultations with Mexico concerning its action to ban…

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…