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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 Comments to FDA on Using Artificial…
In response to the agency's request for information (Docket No. FDA-2023-N-0743-0002), BIO provides detailed comments.
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BIO Comments on the NIH Technology Transfer…
BIO provides detailed comments in advance of the July 31, 2023 NIH Workshop, “Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.
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BIO Comment on EU Compulsory Licensing Legislation
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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…
Testimony on Intellectual Property Protections in the Life Sciences
June 7, 2023
The global IP framework has enabled lifesaving innovation and provides a reliable legal foundation for companies to voluntarily license their IP to enhance research collaborations and provide timely, equitable global access to safe and effective…
Letter in support of U.S. Codex Office funding
May 30, 2023
BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level. 
BIO Comments to FDA (Docket No. FDA-2023-N-0398) on Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
May 26, 2023
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
BIO Comments to the FDA on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (Docket No. FDA–2023-D-0110)
May 25, 2023
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.