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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
Notice of Request for Public Comments on Section…
The Biotechnology Innovation Organization (BIO) offers this submission in response to the request by the Department of Commerce for comments on section 232 national security investigation of imports of pharmaceuticals and pharmaceutical ingredients…
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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…
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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…
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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On Tuesday, September 13th, BIO submitted comments in response to the FDA’s recent draft guidance on voluntary consensus standards (VCS) for regenerative medicine therapies.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…
Letter Supporting Doug McKalip as USTR Ag Negotiator
July 7, 2022
A coalition of 96 food and agriculture organizations signed a letter supporting the nomination of Doug McKalip as the Chief Agricultural Negotiator at the Office of the U.S. Trade Representative. The letter to Senate Finance Committee leadership…
BIO Comments on APHIS Strategic Plan Framework
July 5, 2022
BIO Sends Letter to Senate Ag Committee Supporting Alexis Taylor to Serve as USDA Under Secretary for Trade and Foreign Agricultural Affairs
June 24, 2022
We write to express our support for the nomination of Oregon Department of Agriculture Director Alexis Taylor to serve as the U.S. Department of Agriculture’s Under Secretary for Trade and Foreign Agricultural Affairs. U.S. agricultural producers…