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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 on DoL Proposed Rule, “Improving…
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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 to FTC on Revised HSR Form
September 27, 2023
Comments on Revised HSR Premerger Notification and Report Form 16 CFR Parts 801-803—Hart-Scott-Rodino Coverage, Exemption, and Transmittal Rules, Project No. P239300
Testimony of John F. Crowley, Executive Chairman of Amicus Therapeautics, to the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations  for the hearing “How the IRA’s Price Setting Scheme Means Fewer Cures for Patients”
September 20, 2023
BIO Board Vice Chair and CEO of Amicus Therapeutics testified that the drug price controls in the Inflation Reduction Act harm drug research and development.
Coalition Letter Supporting Ag Research Funding
September 11, 2023
BIO joined with other groups in writing House and Senate Agriculture Committee leaders in support of agricultural research (FFAR) funding in the farm bill. 
BIO Comments to FDA on Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products
August 3, 2023
In response to the agency's request for information (Docket No. FDA-2023-N-0743-0002), BIO provides detailed comments.
BIO Comments on the NIH Technology Transfer Workshop
August 1, 2023
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.
BIO Comment on EU Compulsory Licensing Legislation
July 31, 2023
BIO Statement to the Senate 340B Bipartisan Working Group on Safeguarding and Strengthening 340B
July 28, 2023
In response to a Request for Information (RFI) from the Senate 340B Bipartisan Working Group, BIO submitted detailed comments on the current status of the program and suggestions for improvements.
BIO Comments to FDA on Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices
July 26, 2023
BIO submitted general comments and specific recommendations to the FDA in response to the agency's request for information. (Docket FDA-2022-D-2870)
BIO Comments to Centers for Medicare & Medicaid Services, Department of Health and Human Services RE: CMS–2434–P
July 25, 2023
BIO submitted comments to CMS per their Notice of Proposed Rulemaking: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program.
BIO Comments to FDA on Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development
July 20, 2023
BIO submitted comments on the recent Rare Disease Endpoint Advancement (RDEA) Pilot Program Workshop, held June 7-8, 2023 (Docket No. FDA-2022-N-2480)