FDA Roundup: February 21, 2023

FDA News Release

• For Immediate Release: February 21, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Friday, the FDA published the FDA Voices: “Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In the first of a two-part series, Dr. Califf reflects on his one-year anniversary back at the agency and shares his vision for the future of the agency and its mission to protect and promote public health amid the enormous workload and societal forces that make the mission more challenging than in other times.
• On Friday, the FDA announced that after a robust recruitment and interview process, Tracey Forfa, J.D., a distinguished 30-year veteran of the agency, has been selected as the next Director of the FDA’s Center for Veterinary Medicine (CVM), effective February 26, 2023. Ms. Forfa has been acting in the position since Steven M. Solomon, D.V.M., M.P.H, retired in December.
• On Friday, the FDA authorized for marketing the Medasense Biometrics Ltd. PMD-200 with the Nociception Level (NOL) Index monitoring system to help health care specialists assess the physiological response to painful stimuli in anesthetized patients receiving opioid medications as part of their treatment. The PMD-200 is indicated to be used adjunctively to help health care specialists tailor the administration of opioid-based analgesics in anesthetized patients. Nociception is the process by which the body’s nervous system reacts to unpleasant or harmful stimuli that results in the sensation of pain. The NOL Index is part of the software in the PMD-200 and it is calculated based on physiological parameters extracted from raw data signals. Interpretation of the NOL index along with other vital sign readings should always be used in conjunction with health care specialists’ clinical judgment when making treatment decisions for patients.
• COVID-19 testing updates: 
  • As of today, 442 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 84 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 1244 revisions to EUA authorizations.