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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 on AR HB1531
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BIO Comments to Pharmacy Compounding Advisory…
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BIO Comments on OMB Proposed Rule "Regulation for…
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BIO Comments to FDA on Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
October 27, 2023
BIO submits comments and specific recommendations to the U.S. Food and Drug Administration on their Draft Guidance for Industry (Docket No. FDA-2023-D-2436)
CSBA letter to Centers for Medicare & Medicaid Services (RE: CMS-2434-P)
October 19, 2023
On behalf of CSBA, BIO submitted this MDRP sign-on letter to CMS, which strongly urged the agency to refrain from finalizing a proposal that would drastically impact the Medicaid Best Price calculation.
BIO Comments on NIH Proposed GDMO Research Guidelines
October 13, 2023
BIO submitted comments to the National Institutes of Health in response to the agency's request for comment on a proposal to review NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to include specific…
BIO Comments to FDA on Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials (FDA-2022-D-2629)
October 10, 2023
In response to their request for information, BIO submitted these comments, including line-by-line recommended edits.
BIO Comments to the Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)
September 29, 2023
BIO submitted comments to DoD, GSA, and NASA on the Proposed Rule to amend and restructure regulations on environmental and sustainability procurement (FAR Case 2022-006, Docket No. 2022-0006, Sequence No. 1 RIN 9000-AO43)
BIO's Comments on FTC Merger Guidelines
September 28, 2023
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.