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FDA Roundup: May 17, 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 published the FDA Voices: “FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program,” Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of CDER. The FDA will hold a two-day workshop on May 24 and 25 for stakeholders to learn more about a quality management program and to engage with the agency. The workshop is hosted by the CDER’s Small Business and Industry Assistance and will include speakers and panelists from outside the FDA to discuss quality management maturity.
  • On May 15, the FDA issued an Emergency Use Authorization (EUA) for the Laboratory Corporation of America (Labcorp) Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test. The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test: 
    • Is the first COVID-19 direct-to-consumer (DTC) test that also detects and differentiates influenza A and B (flu), and Respiratory Syncytial Virus (RSV), allowing a person to self-collect a nasal sample in their home and then send the sample to Labcorp for testing, all without a prescription. 
    • Can be used for people with symptoms of respiratory viral infection consistent with COVID-19. 
    • Can be purchased online or in a store without a prescription. 
    • The test can be used for people:
      • Age 18 years and older with a self-collected nasal swab sample.
      • Age 14 years and older with a self-collected nasal swab sample under adult supervision.
      • Age 2 years and older when an adult collects the nasal swab sample.
      • Results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results
  • On May 13, the FDA issued a Class I recall notification for the Avanos Medical Cortrak*2 Enteral Access System because there have been reports of injuries and patient deaths after using the device to assist with the placement of medical feeding tubes in the stomach or small bowel. If a feeding tube is misplaced, patients could experience damage to the lung, trachea, or bowel, which can lead to serious injury or death.
  • On May 12, the FDA and the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response issued a statement that the shelf-life of sotrovimab continues to be evaluated. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. However, it is recommended that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. All sotrovimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. This recommendation applies to all unopened vials of sotrovimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.
  • COVID-19 testing updates:
    • As of today, 433 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 83 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 78 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 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 972 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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