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 Comments on APHIS Strategic Plan Framework
BIO Comments on FDA Guidance on Improving…
On Monday, June 13th, BIO submitted comments in response to a recently published FDA draft guidance providing recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in clinical trials…
BIO Sends Letter to Senate Ag Committee…
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…
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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…
June 17, 2022
The Biotechnology Innovation Organization (BIO) is pleased to offer comments in response to the Office of Science and Technology Policy (OSTP) request for information on sustainable chemistry. Specifically, we seek to inform the development of a…
June 15, 2022
The Biotechnology Innovation Organization (BIO), BIO members and State affiliates urge immediate legislative action to repeal the harmful R&D amortization provision that went into effect earlier this year. The 2017 Tax Cuts and Jobs Act (TCJA)…
June 12, 2022
On Monday, June 13th, BIO submitted comments in response to a recently published FDA draft guidance providing recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in clinical trials…
June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on Chimeric antigen receptor (CAR) T cell products (i.e., human gene therapy products in which the T cell specificity is genetically modified to enable recognition…
June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells. Overall, BIO found the guidance to be a well-written resource…
June 7, 2022
On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted…
May 24, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House of Representatives Select Committee on the Climate Crisis hearing entitled, “Climate Smart From Farm to Fork: Building…
May 9, 2022
On Monday, May 9th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. In the comments submitted, BIO acknowledged the challenge FDA faces in creating a…