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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 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On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what…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On Tuesday, September 13th, BIO submitted comments in response to the FDA’s recent draft guidance on voluntary consensus standards (VCS) for regenerative medicine therapies.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…
BIO Letter on Inflation Reduction Act Implementation, Climate & Biotechnology
September 8, 2022
As the federal government begins to implement IRA, BIO urges the administration to take additional steps to foster the development and deployment of pioneering technologies that will further reduce greenhouse gas emissions in manufacturing,…
BIO Comments on FDA Guidance for Risk Management Plans to Mitigate the Potential for Drug Shortages
August 31, 2022
Today, BIO submitted comments in response to the FDA’s recent draft guidance on the development, maintenance, and implementation of Risk Management Plans (RMPs). While the comment letter expressed broad support for the systematic approach for…
BIO Applauds Senator Tom Tillis for Introducing the Patent Eligibility Restoration Act
August 2, 2022
On behalf of the Biotechnology Innovation Organization, I want to thank you for introducing the Patent Eligibility Restoration Act. This important legislation will bring much-needed and overdue clarity to Section 101 of the Patent Act. The existing…
CSBA Sends Letter to Congressional Leadership on Negative Impacts of Democrats' Drug Pricing Proposal
July 29, 2022
The Council of State Bioscience Associations (CSBA) is an alliance of independent, state and territory based, non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative…
BIO Statement for House Select Committee on the Climate Crisis Hearing
July 15, 2022
BIO submitted a statement for the record to the U.S. House of Representatives Select Committee on the Climate Crisis for the committee's hearing titled "Climate Smart From Farm to Fork: Building an Affordable and Resilient Food Supply Chain." BIO's…