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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 Congressional Leadership on the…
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
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John F. Crowley's One-Year Anniversary Letter to…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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BIO letter to FDA on Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies
November 17, 2023
BIO submits comments in response to the agency’s request for information (FDA-2023-N-3742)
BIO letter to FDA on Labeling for Biosimilar and Interchangeable Biosimilar Products
November 17, 2023
BIO submits specific comments and recommended edits on the draft guidance 2016-D-0643
Letter to House and Senate Judiciary Committee Leadership on FTC-DOJ Regulation of Mergers
November 14, 2023
BIO joins 30 other national trade associations in speaking out against unprecedented and burdensome FTC-DOJ regulation of mergers
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…