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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'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BIO Comments on FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and…
BIO Comments on FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug…
BIO Comments on FDA Draft Guidance on Postapproval Pregnancy Safety Studies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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments to the Draft Guidance on Postapproval Pregnancy Safety Studies.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BIO Comments on FDA Draft Guidance on Rare Diseases: Natural History Studies for Drug Development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 The Draft Guidance serves as an important communication tool between the FDA and Sponsors on issues pertaining to…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…
BIO Submits Comments on FDA Draft Guidance, Rare Diseases: Common Issues in Drug Development
April 11, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the Draft Guidance on Rare Diseases: Common Issues in Drug Development. BIO is the world’s largest trade…