Letters, Testimony & Comments

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…

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…

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…

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…

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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug…

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…

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…

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…

Undermining the RFS at a time when rural America is struggling economically, farmers are fighting to stay in business, and the biofuels industry has been impacted by furloughs and plant closures is unconscionable. We respectfully urge you to reject…

We urge you to direct the EPA to reject all calls to waive the RFS. The RFS is more important now than ever as farmers, the biofuel sector, and rural America struggle to remain operating amid the COVID-19 crisis.