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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
Testimony of BIO President & CEO John F. Crowley…
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000…
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BIO Statement on Vaccines and Autism
Phyllis Arthur, EVP, Health Policy and Programs, “Vaccines are one of the most important and effective innovations for the defense of public health. They have saved millions of lives and drastically reduced or eliminated deadly and debilitating…
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BIO's Comments to CDC’s Advisory Committee on…
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
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Letter to Congress Re Tax Treatment of R&D Expenses
October 11, 2022
Nearly 400 companies and trade associations wrote House and Senate leaders about the need to reverse a harmful tax change--a new requirement to amortize R&D expenses--that threatens jobs and innovation.
Coalition Letter to Pres. Biden on High-Level Economic Dialogue with Mexico
September 29, 2022
BIO and 24 other organizations call on the Biden Administration to discuss supply chains and food security in future High-Level Economic Dialogue meetings.
BIO Comments on ICH Guidelines: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
September 28, 2022
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
BIO Submits Comments on FDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
September 26, 2022
On Monday, September 26th, BIO submitted comments in response to the FDA’s draft guidance on clinical pharmacology considerations for development of oligonucleotide therapeutics, which provided recommendations on when certain PKPD assessments may be…
BIO Sends Letter to President Biden Strongly Opposing Expansion of the WTO TRIPS Waiver
September 26, 2022
We are writing to express our strong opposition to any form of expansion of the WTO TRIPS waiver to COVID-19 therapeutics or diagnostics. Support for an intellectual property (IP) waiver would send U.S.-developed innovative technologies and…
BIO Comments on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
September 23, 2022
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
BIO Submits Comments on FDA Guidance: Conducting Remote Regulatory Assessments – Q&As
September 23, 2022
On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what…
BIO Joins Letter to Congress Urging for Expeditious Confirmation of Doug McKalip as Chief Agricultural Negotiator at USTR
September 21, 2022
On behalf of the broad and diverse stakeholders in American Agriculture we represent, we urge you to work with your colleagues to expeditiously confirm Doug  McKalip as Chief Agricultural Negotiator at the Office of the U.S. Trade…
BIO Comments on FDA Guidance: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
September 13, 2022
On Tuesday, September 13th, BIO submitted comments in response to the FDA’s recent draft guidance on voluntary consensus standards (VCS) for regenerative medicine therapies. In the comment letter, BIO expressed appreciation to FDA for issuing a…
BIO Comments on WHO White Paper: Regulation of Cell and Gene Therapy Products
September 9, 2022
Today, BIO submitted comments to the World Health Organization (WHO) regarding its revised, draft white paper on the regulation of Cell and Gene Therapy Products (CGTPs). As stated previously, BIO emphasized that this paper represents a major…