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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 HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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Rare Diseases: BIO Comments on Rare Disease Clinical Trial Network Request for Information
July 31, 2020
July 31, 2020 Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the…
BIO Submits Comments to USDA on Ag Innovation
July 31, 2020
The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations. BIO applauds USDA for taking a proactive approach and seeking…
Data Modernization: BIO Comments on Modernizing the Food and Drug Administration’s Data Strategy
July 30, 2020
July 30, 2020 Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or…
BIO Joins Letter to FDA Commissioner on Clarifying Guidance for Plant Gene Editing
July 29, 2020
New innovations capable of advancing plant breeding, such as gene editing, have immense potential to improve agriculture and food production. Researchers are exploring genetic innovations aimed at increasing agricultural productivity; improving…
BIO Comments on Proposed Rule on Value-Based Arrangements
July 20, 2020
The following letter provides BIO’s feedback on a number of regulatory proposals by the Centers for Medicare & Medicaid Services that would ease barriers to use of value-based purchasing arrangements within Medicaid and commercial plans, broaden…
BIO Signs Letter to Congress Urging More Relief for Agriculture Amid COVID-19
July 9, 2020
As Congress develops and debates additional bipartisan legislation in response to COVID-19 and the resulting impacts to workers and the economy, the economic losses persisting across U.S. agriculture must be addressed in the legislation and in…
Orphan Drugs: BIO Comments on Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
June 23, 2020
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug…
Letter to Congress to Support Animal Health Infrastructure Amid COVID-19
June 19, 2020
On behalf of the Animal Agriculture Coalition (AAC), representing veterinary medicine, animal science, state agricultural leaders, and various livestock or animal agricultural interests in the U.S., we applaud lawmakers’ ongoing attention to the…
BIO and CSBA Letter to Congress to Support One Health and Advance Animal Biotech
June 2, 2020
The Biotechnology Innovation Organization (BIO), along with the 27 members of the Council of State Bioscience Associations (CSBA), urge Congress to support the Advancing Emergency Preparedness Through One Health Act and advance legislation…
An Inclusive and Impactful Approach to Transparency
May 14, 2020
The U.S. government’s regulatory approach cannot exist in isolation. It should be supported by credible transparency measures. A proactive approach to transparency stands to build trust and foster an inclusive environment to address our most…