Letters, Testimony & Comments

September 22, 2020 Re: Docket No. FDA-2019-N-5553: Annual Summary Reporting Requirements Under the Right to Try Act, Proposed Rule Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or…

September 27, 2020 Re: Docket No. FDA-2014-D-1551:  FDA Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format. Dear Sir/Madam: The…

We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…

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…

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…

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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug…