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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 Statement on Vaccines and Autism
Phyllis Arthur, EVP, Health Policy and Programs, “Vaccines are one of the most important and effective innovations for the defense of public health. They have saved millions of lives and drastically reduced or eliminated deadly and debilitating…
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BIO's Comments to CDC’s Advisory Committee on…
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
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CSBA Letter to Congressional Leaders Supporting…
Dear Majority Leader Thune, Minority Leader Schumer, Speaker Johnson, and Minority Leader Jeffries:The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory based non-profit trade associations, each of…
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19 Congressional Democrats send letter to USTR on Trips Waiver
January 2, 2024
BIO Comments to FDA on “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)
BIO Comments to FDA on “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence”
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)
BIO Comments to FDA on the draft guidance “Regulatory Consideration for Prescription Drug Use-Related Software.”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In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)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