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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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BIO Comments on the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
December 6, 2021
BIO is committed to enhancing clinical trial diversity as part of our BIOEquality Agenda published in the fall of 2020. During the pandemic we witnessed biopharmaceutical companies achieve increased clinical trial diversity through commitment and…
BIO Comments on FDA Draft Guidance, Benefit-Risk Assessment for New Drug and Biological Products
November 29, 2021
On Monday, November 29th, BIO submitted comments in response to a recent FDA draft guidance for industry clarifying how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket…
BIO comments on the Department for Digital, Culture, Media and Sport’s Public Consultation on reforms to the United Kingdom’s data protection regime
November 19, 2021
The Biotechnology Innovation Organization (BIO) welcomes the opportunity to provide comments on the Department for Digital, Culture, Media and Sport’s Public Consultation on reforms to the UK’s data protection regime.
BIO Submits Statement to House Ag Subcommittee Hearing on Trade Policy and Priorities
November 17, 2021
BIO applauds the Subcommittee for examining trade policy and priorities to support agricultural producers, promote innovation, protect the environment and enable agriculture to combat climate change. Because of bipartisan support, for over twenty…
BIO Submits Statement to House Ag Hearing on the Rural Economy
November 16, 2021
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture Subcommittee on Commodity Exchanges, Energy, and Credit hearing on A Look at the…
BIO Comments on ICH Draft Guidance S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
November 8, 2021
On Monday, November 8th, BIO submitted comments to the FDA’s draft guidance on Nonclinical Biodistribution Considerations for Gene Therapy Products. In the comment letter, BIO expressed appreciation for the Agency’s decision to put forth a draft…
BIO Submits Comments to USDA for RFI on Climate-Smart Agriculture Practices
November 1, 2021
To meet the challenge of climate change, it is crucial to lead with science and U.S. innovation. We must incentivize the adoption of innovative, sustainable technologies and practices; and streamline and expedite regulatory pathways for breakthrough…
BIO Signs Letter to Congress on Importance of Qualified Small Business Stock
October 29, 2021
The undersigned organizations write to encourage policymakers to remove provisions in the Build Back Better Act that would curtail the effectiveness of Qualified Small Business Stock (QSBS) in incentivizing investment in innovative small businesses…
Agriculture Biotech Alliance Letter to House Ag Committee on Importance of Biotechnology
October 26, 2021
On behalf of our nation’s food and agricultural stakeholder community, we write to extend our appreciation for holding today’s hearing on “Agricultural Biotechnology: 21st Century Advancements and Applications.” Biotechnology is an increasingly…
BIO Submits Statement to House Ag Joint Hearing on Agriculture Biotechnology
October 26, 2021
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture joint hybrid subcommittee hearing, Agricultural Biotechnology: 21st Century…