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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 to the FDA on the Agency’s Updated Guidance on PREA and BPCA
July 17, 2023
BIO provides general comments and recommendations on FDA’s Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act (Docket No. FDA-2005-D-0460-0008)
BIO Comments to FDA on Pediatric Drug Development: Regulatory Considerations
July 17, 2023
BIO provides general comments and recommendations to FDA on “Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” (Docket No. FDA-2005-D-0460-0007)
Coalition Letter Re PIPs Rule
July 12, 2023
BIO and 59 other organizations have written to House and Senate Agriculture Committee leaders to ask that they direct Congress to withdraw the current rule concerning regulation of plant incorporated protectants and replace it one based on a science…
BIO Comments to the Senate Committee on Health, Education, Labor and Pensions on the Reauthorization of PAHPA
July 10, 2023
BIO provides detailed comments to the Committee on its draft of the 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), legislation that is critical to our national health security.
BIO comments to FDA on Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
June 29, 2023
BIO submitted general comments and proposed changes to FDA (Docket No. FDA-2023-D-0026)
BIO Recommendations on PTAB patent invalidation proceedings
June 23, 2023
BIO comments on U.S. Patent & Trademark Office proposed reforms to PTAB patent invalidation proceedings.
BIO Comments on Biotech & Biomanufacturing Initiative
June 13, 2023
BIO comments to the Office of Management & Budget in response to the agency’s request for information on measuring and classifying the bioeconomy for potential inclusion in the North American Industry Classification System (NAICS) and North…
BIO testimony at the House Energy & Commerce Committee hearing, “Legislative Solutions to Bolster Preparedness and Response for All Hazards and Public Health Security Threats.”
June 13, 2023
Presented by Phyllis Arthur, MBA, BIO’s Senior Vice President of Infectious Disease and Emerging Science Policy.
BIO Comments to FDA on the agency’s Data and Technology Strategic Plan (Docket No. FDA–2023-N-1052)
June 12, 2023
BIO applauds FDA’s efforts to develop a plan consistent with PDUFA VII commitments and the FY23 Omnibus Bill and offers strategic recommendations.
BIO Testimony on Restoring R&D Tax Deduction
June 7, 2023
Biotechnology Innovation Organization statement for the record to the U.S. House Committee on Small Business Subcommittee on Economic Growth, Tax, and Capital Access hearing on "American Ingenuity: Promoting Innovation Through the Tax Code…