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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 an Emergency Use Authorization (EUA) to Roche Molecular Systems, Inc. for the cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (EUA220459) for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox virus infection by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests.
- Today, the FDA released an outline of a prevention strategy under development to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. This prevention strategy is being developed following a large-scale recall of powdered infant formula earlier this year. Powdered infant formula was recalled because FDA investigators found insanitary conditions in a manufacturing facility, which possibly contributed to Cronobacter sakazakii infections in four infants. The outline released today is intended to guide discussions during further development of the FDA’s strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. In the coming weeks, teams from across the FDA will be meeting with stakeholders to further discuss, hear their ideas, and finalize the prevention strategy. Following this engagement, we intend to release an updated summary of the powdered infant formula strategy on FDA.gov.
- On Thursday, the FDA, in conjunction with the CDC, released results on youth tobacco use from the 2022 National Youth Tobacco Survey. Findings show that in 2022, more than one in 10 middle and high school students (3.08 million) had used a tobacco product during the past 30 days - including 16.5% of high school and 4.5% of middle school students. The full results are available here.
- On Thursday, the FDA advised consumers to learn as much as they can, including the risks and benefits, before deciding whether to enroll their child in a clinical trial. Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat and sometimes even cure, childhood diseases. Children who participate in these research studies may also potentially benefit from the medical products under investigation.
- On Nov. 8, the FDA issued an emergency use authorization (EUA) for Kineret (anakinra) injection for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is currently FDA-approved for the treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes and deficiency of IL-1 receptor antagonist. Common side effects of Kineret and the recommended dosage for the authorized population are included in the EUA Fact Sheet for Health Care Providers. Additional information on authorized treatments is available on the FDA’s Emergency Use Authorization webpage.
- COVID-19 testing updates:
- As of today, 437 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests and 4 for molecular OTC at-home tests.
- The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1157 revisions to EUA authorizations.
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