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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 FDA Guidance: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cells Products
June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on Chimeric antigen receptor (CAR) T cell products (i.e., human gene therapy products in which the T cell specificity is genetically modified to enable recognition…
BIO Comments on FDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing
June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells. Overall, BIO found the guidance to be a well-written resource…
BIO Comments on FDA Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies
June 7, 2022
On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted…
BIO Sends Letter to House Committee on Climate Crisis on Building a Resilient Food Supply
May 24, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House of Representatives Select Committee on the Climate Crisis hearing entitled, “Climate Smart From Farm to Fork: Building…
BIO Comments on FDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
May 9, 2022
On Monday, May 9th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. In the comments submitted, BIO acknowledged the challenge FDA faces in creating a…
BIO Submits Comments to FTC on PBM Business Practices
May 5, 2022
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Federal Trade Commission’s (FTC’s or the Commission’s) Solicitation for Public Comments on the Business Practices of Pharmacy Benefit Managers and…
BIO Letter to Senate Appropriations Committee on Priorities for Fiscal Year 2023 Energy and Water Development and Related Agencies Appropriations Act
May 4, 2022
Industrial biotechnology is enabling a dramatic paradigm shift in the production of fuels and chemicals. Modern biorefineries are converting domestic sources of renewable biomass, wastes, and residues into sustainable low carbon fuels, chemicals,…
BIO Letter to Senate Appropriations Committee on Priorities for Fiscal Year 2023 Labor, Health and Human Services, Education and Related Agencies Appropriations Act
May 4, 2022
The Biotechnology Innovation Organization (BIO) is the largest biotechnology trade association, representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United…
BIO Letter to Senate Appropriations Committee on Priorities for Fiscal Year 2023 Interior, Environment, and Related Agencies Appropriations Act
May 4, 2022
The value of science and agricultural innovation cannot be understated. The adoption of biotechnology in agriculture and the development of biobased technologies contribute to food security, sustainability, and climate change solutions. Over the…
BIO Letter to Senate on Key Priorities for Fiscal Year 2023 Agriculture, Rural Development, FDA and Related Agencies Appropriations Act
May 4, 2022
BIO supports public policies centered on innovation to incentivize the adoption of cutting-edge technologies and practices to maintain America’s leadership and benefit our rural economies. Further, it is crucial that the government establish risk…