Home
Search

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 Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
Learn more
CSBA Letter to Congressional Leadership on…
Learn more
BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
Learn more
All Letters, Testimony & Comments
  • Show All
Search
Results
Comments to Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights
February 7, 2024
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
BIO Comments to Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (NIST–2023–0008), 88 Fed. Reg. 85593
February 7, 2024
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
BIO Comment - USPTO FRN on WIPO IGC DIPCON
January 30, 2024
BIO provides comments to the Office of Policy and International Affairs, U. S. Patent and Trademark Office (Docket ID: PTO-C-2023-0019)
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