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  5. FDA Roundup: April 19, 2022
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FDA News Release

FDA Roundup: April 19, 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 FDA issued its final rule titled "Beverages: Bottled Water". This final rule amends the allowable level for fluoride in domestically packaged and imported bottled water to which fluoride is added to 0.7 milligrams per liter (mg/L). The proposed rule published in April 2019.
  • Today, the FDA announced a draft revision of the guidance “The Use of Published Literature in Support of New Animal Drug Approvals,” which will be open for public comment on April 20. The document provides guidance to animal drug sponsors on specific areas of the approval process where the available scientific literature may be useful to support the approval of a new animal drug application, an abbreviated new animal drug application or a conditionally approved new animal drug application. 
  • Today, the FDA, in cooperation with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), its partners in the National Antimicrobial Resistance Monitoring System (NARMS), released the NARMS Integrated Summary 2019. NARMS is a national public health surveillance system that monitors certain pathogens in human and animal samples for resistance to antimicrobial drugs used in human and veterinary medicine. The NARMS Integrated Summary 2019 combines antimicrobial resistance data in bacteria isolated from humans (by the CDC), raw retail meats (by the FDA) and animals at slaughter (by the USDA) to examine trends in resistance, prioritizing antimicrobial agents that are most important to human medicine.
  • On Monday, the FDA released a Constituent Update spotlighting research on the seasonal effects linked to E. coli outbreaks in bagged romaine lettuce. Scientists from the FDA’s Center for Food Safety and Applied Nutrition and the U.S. Department of Agriculture’s Agricultural Research Service (USDA ARS) have been working collaboratively to understand the seasonal effects and other factors that may be contributing to outbreaks of E. coli O157:H7 linked to bagged romaine lettuce—and they are making significant progress. Leafy greens, including bagged romaine lettuce, have been implicated in outbreaks of foodborne illness caused by Shiga toxin-producing E. coli (STEC), the most common of which is E. coli O157:H7.
  • COVID-19 testing updates:
    • As of today, 431 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 296 molecular tests and sample collection devices, 84 antibody and other immune response tests, 50 antigen tests and 1 diagnostic breath test for SARS-CoV-2. There are 77 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests and 3 for molecular OTC at-home tests.
    • The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 934 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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