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  5. FDA Roundup: December 20, 2022
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FDA News Release

FDA Roundup: December 20, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

  • Today, the agency published a piece for FDA Voices: “Office of Digital Transformation’s New Focus on Technology Leadership,” by Vid Desai, Chief Information Officer and Jessica N. Berrellez, Executive Officer. The Office of Digital Technology's (ODT) technology-focused Leadership Modernization Action Plan (LMAP) is the next milestone in the enterprise transformation journey. The LMAP lays out ODT’s plans to strengthen the technology leadership capabilities to effectively drive change at the business, technology, data, and cybersecurity levels. The LMAP is the final piece of the agency's technology Modernization Frameworks that are in action today and places people, and technology leaders, at the forefront of these efforts.
  • Today, the FDA approved Zycosan (pentosan polysulfate sodium injection) for the control of clinical signs associated with osteoarthritis in horses. Unapproved injectable formulations (including compounded formulations) of pentosan have a long history of use in horses, but Zycosan is the first injectable pentosan product to receive FDA’s approval. FDA-approved drugs, like Zycosan, have been demonstrated to be safe and effective for their intended use and have been consistently manufactured to preserve the drugs’ identity, strength, quality and purity. The FDA strongly encourages veterinarians to use Zycosan (pentosan polysulfate sodium injection) instead of unapproved drugs in their equine patients. 
  • Today, the FDA issued an emergency use authorization (EUA) for the ImmuView COVID-19 Antigen Home Test (manufactured by CTK Biotech, Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people within the first 7 days of symptom onset or for people who do not have symptoms.  
  • Today, the FDA issued a final guidance titled Best Practices for Convening a GRAS Panel. Although in most cases general recognition of safety can be supported without convening a GRAS panel, this guidance provides information to those assembling a panel of experts (“GRAS panel”) to evaluate whether there is general acceptance among the scientific community that the publicly available scientific data and information demonstrate that a substance is safe under the conditions of its intended use in human or animal food.
  • On Monday, the White House Office of Science and Technology Policy (OSTP) — in coordination with the FDA, U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) — announced a request for information (RFI) related to the Coordinated Framework for the Regulation of Biotechnology. This RFI requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The RFI also seeks information and other data, including case studies, that relate to new and emerging biotechnology products.
  • COVID-19 testing updates: 
    • As of today, 441 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 86 antibody and other immune response tests, 56 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 23 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
    • The FDA has authorized 40 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1184 revisions to EUA authorizations

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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