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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 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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CSBA Letter to Congressional Leadership on…
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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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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BIO Comments on FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and…
BIO Comments on FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug…
BIO Comments on FDA Draft Guidance on Postapproval Pregnancy Safety Studies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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments to the Draft Guidance on Postapproval Pregnancy Safety Studies.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.
BIO Comments on Prescription Drug-Use-Related Software
April 29, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the open docket on Prescription Drug-Use-Related Software.
BIO Comments on Safety Labeling Changes and Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
April 15, 2019
BIO submitted comments on the Food and Drug Administration (FDA)’s request for comments on safety labeling changes and implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA’s statements and estimates refer…