FDA Roundup: February 10, 2023

FDA News Release

• For Immediate Release: February 10, 2023

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) for the Cepheid Xpert Mpox test for use in a point-of-care setting. Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program established as a collaboration between the FDA and the NIH. This EUA is the latest example of the FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases. The Xpert Mpox test is a real-time polymerase chain reaction test intended to detect Mpox virus DNA in lesion swab specimens from individuals suspected of monkeypox by their health care provider.
• On Thursday, the FDA has issued draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to help them in the design, conduct, evaluation and reporting of Protein Efficiency Ratio (PER) rat bioassay studies.  
• On Thursday, the FDA provided updated information about medical device reports that the FDA received from Nov. 1, 2022 to Dec. 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Since April 2021, the FDA has received more than 98,000 medical device reports, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.
• On Tuesday, the FDA revised the immediately-in-effect guidance on compounding certain ibuprofen products, initially issued January 20. The FDA published this update to address increased demand for fever-reducing medications among state licensed pharmacies, in addition to hospitals and health-systems. The revision addresses the provision of certain compounded ibuprofen products to state licensed pharmacies (including those within hospitals and health systems), and to applicable federal facilities, for dispensing to patients following receipt of a patient-specific prescription. More information is available in the CDER Statement. 
• COVID-19 testing updates: 
  • As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 85 antibody and other immune response tests, 58 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1225 revisions to EUA authorizations.