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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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Stakeholder Letter on PAHPA Reauthorization
November 14, 2023
BIO joined other stakeholders to urge Congressional leaders to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA).
BIO and BIO member Letter to Congressional Leadership on the Medical Countermeasures (MCM) Priority Review Voucher (PRV) program
November 10, 2023
BIO and BIO members are urging lawmakers to enact a short-term extension of the MCM-PRV program while Congress is waiting to address a full reauthorization with PAHPA.
BIO Letter to CMS Urging for Formulary Management Reforms to Medicare Part D
November 8, 2023
To protect patient access to critical prescription drugs, BIO has identified Part D guardrails (both MA-PD and PDP) for consideration as CMS develops guidance to plans for CY2025 and beyond.
Comments to FDA on the Agency’s Information Technology Strategy
October 30, 2023
BIO and PhRMA submitted joint comments on the U.S. Food and Drug Administration’s Information Technology Strategy (Docket No. FDA-2023-N-3636)
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BIO submits comments and specific recommendations to the U.S. Food and Drug Administration on their Draft Guidance for Industry (Docket No. FDA-2023-D-2436)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