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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
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 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…
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Open Letter to the President of the United States: The Need for U.S. Leadership in Global Vaccinations
August 10, 2021
We want to commend you and your Administration for the global distribution of millions of doses of the COVID-19 vaccines. Our friends in recipient countries are truly grateful. Nonetheless, in order to gain control of the pandemic, a much more…
BIO Comments on Core PROs in Cancer Clinical Trials
August 9, 2021
On Thursday, June 10th, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance, Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials, providing recommendations to sponsors on the collection of a core set of patient…
BIO Submits Comments to the USPTO on Discretion to Institute Trials Before the Patent Trial and Appeal Board
August 6, 2021
BIO submitted comments to the United States Patent and Trademark Office in response to the USPTO's consideration of “the codification of its current policies and practices, or the modification thereof,” relating to the exercise of its discretion…
Cartier Esham’s Testimony to Energy and Commerce Health Subcommittee on Treatments and Cures for Neurodegenerative Diseases
July 30, 2021
BIO regularly publishes reports that help us assess the health of the biopharmaceutical pipeline across different diseases so that we can identify and remove barriers to providing next generation cures and treatments to patients and their families…
Phyllis Arthur's Testimony to Senate HELP Committee on Lessons Learned from Covid-19
July 27, 2021
COVID-19 will not be our last public health emergency.  We face numerous bio-threats from natural and bioterror threats.  Strong support for medical countermeasures R&D is critical to protecting our national security. Today I will…
Dr. Michelle McMurry-Heath's Testimony to Senate Finance Committee on USMCA
July 27, 2021
Chairman Wyden, Ranking Member Crapo, Members of the Committee, my name is Dr. Michelle McMurry-Heath. I am the President and CEO of the Biotechnology Innovation Organization (BIO). I am honored to testify before you for today’s hearing,…
BIO Comments on Cures 2.0 Discussion Draft
July 22, 2021
The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30…
BIO Comments on International Council for Harmonisation Q12: Implementation Considerations for FDA-Regulated Products
July 21, 2021
BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of…
BIO Signs on to Letter in Support of Under Secretary for Farm Production and Conservation Robert Bonnie
July 20, 2021
We write to express our support for the nomination of Robert Bonnie to serve as the U.S. Department of Agriculture’s Under Secretary for Farm Production and Conservation. The Under Secretary position is critical in overseeing the administration of a…
BIO Submits Comments on FDA Manufacturing, Supply Chain, and Inspections Guidances & Report
July 16, 2021
On Wednesday, July 14th, BIO submitted comments on FDA’s Guidances: 1) Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance; 2) Updated Manufacturing, Supply…