FDA Roundup: March 21, 2023

FDA News Release

• For Immediate Release: March 21, 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 completed its second pre-market consultation for a human food made from cultured animal cells. The firm will use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make the cultured animal cell food. The voluntary pre-market consultation is not an approval process. Instead, it means that after our careful evaluation of the data and information shared by the firm, we have no further questions at this time about the firm’s safety conclusion. Before entering the U.S. market, the food must meet federal requirements. Information about this pre-market consultation is available on the FDA’s Human Food Made with Cultured Animal Cells Inventory (fda.gov).
• Today, the FDA posted a warning letter to www.ivermectin4covid.com for offering drugs for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
• On Monday, the FDA approved an expanded indication for the Inspire Medical Systems, Inc., Inspire II Upper Airway Stimulator (UAS) system to add certain pediatric patients, between 13 and 18 years of age, with Down syndrome and severe obstructive sleep apnea (OSA). This device is an implantable nerve stimulator that detects the patient’s breathing pattern and maintains an open airway with mild stimulation of the nerves of the tongue. The patient, using a “remote control”- like device turns therapy on before sleep and turns therapy off on awakening. The UAS implant was initially approved in 2014 to treat certain patients, 22 years of age or older with moderate to severe OSA and in 2020, the indication was expanded to include certain adolescent patients between 18 and 21 years of age with moderate to severe OSA.  
• COVID-19 testing updates: 
  • As of today, 445 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 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, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and five for molecular OTC at-home tests.
  • The FDA has authorized 45 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1305 revisions to EUA authorizations.