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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
Comments of the Biotechnology Innovation…
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
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BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
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BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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CSBA Letter to Congressional Leadership Urging Support for the ORPHAN CURES ACT
December 7, 2023
This bipartisan and bicameral legislation is aimed at boosting rare disease drug development to ensure that patients have access to innovative therapies.
CSBA Letter in Support of ORPHAN Cures Act
December 7, 2023
The Council of State Bioscience Associations wrote House and Senate leaders to urge support of H.R. 5539 and S. 3131, the Optimizing Research Progress Hope and New Cures Act. 
Letter to Congressional Leaders in Support of 9003 Program
November 30, 2023
BIO Joins the Ag Energy Coalition, 10 allied organizations and 61 companies on a letter to House leadership urging support for the Biorefinery, Renewable Chemical and Biobased Product Manufacturing Assistance program (9003 program) in the Farm Bill…
BIO Comments to FDA on Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
November 21, 2023
BIO provided general comments and recommended edits Re: FDA-2023-D-3031
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.