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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
CSBA Letter to Congressional Leadership…
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John F. Crowley, President and CEO of the…
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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CSBA Letter to Congressional Leadership on Most…
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BIO Comments to FDA on the draft guidance “Regulatory Consideration for Prescription Drug Use-Related Software.”
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)
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.