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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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BIO Comments to USTR as part of the 2024 Special 301 Review, Highlighting Global IP Challenges Around the World
January 30, 2024
BIO provides detailed comments to USTR RE: 2024 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974 (Docket ID: USTR-2023-0014)  
BIO Comments to FDA on their Workshop to Enhance Clinical Study Diversity
January 29, 2024
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
BIO Comments to the U.S. Senate Committee on Health, Education, Labor, and Pensions on Improving and Protecting Access to Gene Therapies
January 22, 2024
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 FDA on Enhancing Adoption of Innovative Clinical Trial Approaches (FDA-2023-N-4489)
January 19, 2024
In advance of the Agency's public workshop on Enhancing Adoption of Innovative Clinical Trial Approaches, BIO outlined specific considerations and plans to participate in the workshop.
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)