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 Comments to the U.S. Senate Committee on…
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Senate Committee on Health, Education, Labor, and Pensions’ (Committee’s) Request for Information on Improving and Protecting Access to Gene Therapies…
BIO Comments to HHS on their proposed Notice of…
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Department of Health and Human Services’ (HHS’) proposed Notice of Benefit and Payment Parameters (NBPP) for 2025.
BIO Comments to HHS Centers for Medicare &…
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions.
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December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)
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In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)
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.
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. 
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…
November 21, 2023
BIO provided general comments and recommended edits Re: FDA-2023-D-3031
November 17, 2023
BIO submits comments in response to the agency’s request for information (FDA-2023-N-3742)
November 17, 2023
BIO submits specific comments and recommended edits on the draft guidance 2016-D-0643
November 14, 2023
BIO joins 30 other national trade associations in speaking out against unprecedented and burdensome FTC-DOJ regulation of mergers