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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
ohn’s One-Year Anniversary Letter to BIO…
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 forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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BIO Comments on FDA Draft Guidance on Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs
August 6, 2019
BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance, Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs. BIO welcomes FDA’s recommendations to broaden…
BIO Comments on USDA's Proposed Part 340 Revisions
August 5, 2019
On behalf of the Biotechnology Innovation Organization (BIO), thank you for the opportunity to provide comments to the United States Department of Agriculture on its June 6, 2019 Proposed Rule regarding the movement of certain genetically engineered…
Congressional Letter to FDA Commissioner Sharpless on Animal Biotech
July 26, 2019
In recent years advances in animal genetics have provided significant breakthroughs that can help to address some of society's most difficult challenges. These technologies can treat and protect animals from illness; limit the transmission of…
BIO Comments on FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
July 19, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and…
BIO Comments on FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
July 8, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug…
BIO Comments on FDA Draft Guidance on Postapproval Pregnancy Safety Studies
July 1, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments to the Draft Guidance on Postapproval Pregnancy Safety Studies.
The Economic Contribution of University/Nonprofit Inventions in the United States: 1996-2017
June 5, 2019
The Economic Contribution of University/Nonprofit Inventions in the United States: 1996-2017
BIO Comments on FDA Draft Guidance on Rare Diseases: Natural History Studies for Drug Development
May 24, 2019
BIO appreciates the Agency’s work to develop a much-needed guidance on natural history studies for rare disease drug development. The Draft Guidance serves as an important communication tool between the FDA and Sponsors on issues pertaining to…
BIO Testimony to the Joint Committee of Taxation
May 14, 2019
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments on LD 1698, HP 1213, An Act To Create Jobs and Slow Climate Change by Promoting the Production of Natural Resources Bioproducts. We strongly support the…
BIO Comments on FDA Draft Guidance on Nonproprietary Naming of Biological Products: Update
May 3, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Nonproprietary Naming of Biological Products: Update.