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 Congressional Leadership on the…
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
Learn more
John F. Crowley's One-Year Anniversary Letter to…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
Learn more
BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
Learn more
All Letters, Testimony & Comments
  • Show All
Search
Results
BIO - USITC Investigation - COVID-19 TRIPS Waiver - Post hearing Supplementary Submission
May 5, 2023
In this Post-hearing Supplementary Written Submission, BIO submits detailed comments to support the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.
BIO Summary of Comments to USITC on COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (ITC Investigation No. 332-596)
May 5, 2023
In this Post-hearing Supplementary Written Submission, BIO submits a 500-word summary of our position on the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.
BIO Comments to FDA (No. FDA–2022-D-2983) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
May 2, 2023
BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.
BIO Comments to FDA–2023-N-0487: Discussion Paper: Artificial Intelligence in Drug Manufacturing
May 1, 2023
In these comments to FDA, BIO supports FDA’s efforts to improve future guidance related to Artificial Intelligence in Drug Manufacturing and outlines recommendations for FDA’s review and further consideration.
BIO Statement for House Financial Services Subcommittee on Capital Markets Hearing: “A Roadmap for Growth: Reforms to Encourage Capital Formation and Investment Opportunities for All Americans”
April 23, 2023
BIO’s Chief Advocacy Officer Nick Shipley presents comments to the Committee as it considers reforms to encourage capital formation and investment opportunities for all Americans.
CSBA Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
April 14, 2023
The CSBA Board of Directors endorses BIO’s formal comments on the Medicare Drug Price Negotiation Program, which are appended to this letter.  
BIO Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
April 14, 2023
BIO comments on the initial guidance regarding the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 issued by CMS on March 15, 2023 (Initial Guidance)
BIO COMMENT LETTER OMB Race and Ethnicity OMB 2023
April 12, 2023
BIO provided detailed comments to the Office of Management and Budget (OMB) regarding the Initial Proposals For Updating OMB’s Race and Ethnicity Statistical Standards.
BIO Comments to FTC
March 31, 2023
BIO response to Federal Trade Commission request for comment on the agency's Guides for the Use of Environmental Marketing Claims (Green Guides)
CSBA Letter to Congressional Leaders urging for passage of S. 866, the American Innovation & Jobs Act of 2023 (March 28, 2023)
March 30, 2023