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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.

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BIO Comments to Pharmacy Compounding Advisory…
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BIO Comments on OMB Proposed Rule "Regulation for…
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CSBA Letter to OMB
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Patient Reported Outcomes: BIO Comments on FDA Draft Guidance Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
October 30, 2020
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology…
BIO Sends Letter to HHS Secretary Alex Azar Urging him to Release Pending Vaccine Clinical Trial Guidance
October 2, 2020
  On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning…
Right to Try: BIO Comments on Annual Summary Reporting Requirements Under the Right to Try Act, Proposed Rule
September 28, 2020
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…
Pediatrics: BIO Comments on FDA Draft Guidance Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format
September 28, 2020
September 27, 2020 Re: Docket No. FDA-2014-D-1551:  FDA Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format.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…
BIO Signs Coalition Letter In Support of the IGNITE American Innovation Act
August 5, 2020
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…
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…