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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 Testimony to House Agriculture Hearing on…
To meet the challenge of climate change, it is crucial to lead with science and U.S. innovation. We must incentivize the adoption of innovative, sustainable technologies and practices; and streamline and expedite regulatory pathways for breakthrough…
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Supporting U.S. Food & Agriculture Innovation &…
Safe, secure, affordable & accessible food supply Hundreds of millions of Americans and people around the world rely on safe and nutritious U.S. agricultural products and foods. Americans have access to one of the safest, most diverse, most…
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BIO Comments on International Council for…
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…
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BIO Testimony to House Agriculture Hearing on Carbon Markets
September 23, 2021
To meet the challenge of climate change, it is crucial to lead with science and U.S. innovation. We must incentivize the adoption of innovative, sustainable technologies and practices; and streamline and expedite regulatory pathways for breakthrough…
Supporting U.S. Food & Agriculture Innovation & Climate Objectives
September 23, 2021
Safe, secure, affordable & accessible food supply Hundreds of millions of Americans and people around the world rely on safe and nutritious U.S. agricultural products and foods. Americans have access to one of the safest, most diverse, most…
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On Thursday, June 10th, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance, Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials, providing recommendations to sponsors on the collection of a core set of patient…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…