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
John F. Crowley's Annual Letter to BIO Membership
Dear Colleagues,  I am just past the two-year mark as BIO’s President & CEO, which arrives as we find ourselves at a defining moment for the future of biotechnology. For fifty years, our industry has delivered one of the great…
BIO Comments on Global Benchmark for Efficient…
BIO Comments on Guarding U.S. Medicare Against…
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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On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.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On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies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On Monday, May 9th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates.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…
May 5, 2022
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Federal Trade Commission’s (FTC’s or the Commission’s) Solicitation for Public Comments on the Business Practices of Pharmacy Benefit Managers and…
May 4, 2022
The Biotechnology Innovation Organization (BIO) is the largest biotechnology trade association, representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United…
May 4, 2022
The value of science and agricultural innovation cannot be understated. The adoption of biotechnology in agriculture and the development of biobased technologies contribute to food security, sustainability, and climate change solutions. Over the…
May 4, 2022
Industrial biotechnology is enabling a dramatic paradigm shift in the production of fuels and chemicals. Modern biorefineries are converting domestic sources of renewable biomass, wastes, and residues into sustainable low carbon fuels, chemicals,…
May 4, 2022
BIO supports public policies centered on innovation to incentivize the adoption of cutting-edge technologies and practices to maintain America’s leadership and benefit our rural economies. Further, it is crucial that the government establish risk…
April 28, 2022
BIO supports public policies centered on innovation to incentivize the adoption of cutting-edge technologies and practices and benefit rural economies. Further, it is crucial that the government establishes risk-proportionate, transparent…