FDA Press Release

19 Jan FDA Press Release

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

• The CDRH Health of Women Program Strategic Plan is now available. CDRH initially issued a proposed strategic plan in September 2019 and considered public feedback to inform our strategic plan. We outline three CDRH Health of Women Program priorities to protect and promote the health of women:
  • Sex and Gender-Specific Analysis and Reporting
  • Integrated Approach for Current and Emerging Issues Related to the Health of Women
  • Research Roadmap
• On Jan. 14, the FDA released a report on its investigation of the Salmonella Typhimurium outbreak that caused 31 reported illnesses and four hospitalizations in the U.S. between June and August 2021. The FDA worked with the U.S. Centers for Disease Control and Prevention and state partners to investigate the outbreak, which was linked through epidemiology and traceback to packaged salad greens during the summer of 2021. This outbreak is believed to be the FDA’s first domestic investigation of a foodborne illness outbreak associated with leafy greens grown in a Controlled Environment Agriculture (CEA) operation. The CEA operation produces leafy greens using common commercial high density hydroponic growing techniques with deep water culture and floating raft production methods. The report includes an overview of the traceback investigation, investigation results and various factors that potentially contributed to the contamination of packaged leafy greens with Salmonella.
• COVID-19 testing updates:
  • As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 44 antigen tests. There are 69 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, three EUAs for antigen prescription at-home tests, 13 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
  • The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 766 revisions to EUA authorizations.