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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's response to HHS Request for Information:…
Below is BIO's formal response to the Department of Health and Human Services' (HHS) request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making 
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HHS TrialBlazer: BIO Comment Letter – FDA 2019-D…
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HHS TrialBlazer: PhRMA-BIO Comment Letter – OIG…
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BIO-ASTA Comments on Movement of Organisms Modified or Produced through Genetic Engineering
January 18, 2024
BIO and the American Seed Trade Association submitted comments on USDA-APHIS' proposed exemptions of five types of genetic modifications a plant can contain and be exempt from regulations for the movement of organisms modified or produced through…
BIO Comments to HHS on their proposed Notice of Benefit and Payment Parameters (NBPP) for 2025
January 8, 2024
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.
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BIO Comments to FDA on the draft guidance “Regulatory Consideration for Prescription Drug Use-Related Software.”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In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)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