The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued a statement in conjunction with preparations to resume domestic inspections, guided by a new a risk-assessment system. The White House Guidelines for Opening Up America Again are providing FDA a roadmap for optimizing operations and new work arrangements, and the Centers for Disease Control and Prevention’s (CDC) guidance is informing efforts related to workplace exposures to COVID-19 in non-healthcare settings. To arm FDA investigators with the most reliable and accurate information, the FDA developed a rating system to assist in determining when and where it is safest to conduct prioritized domestic inspections. The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. The Advisory Level data will be made available to state partners who, under contract, conduct inspections of FDA-regulated entities on the agency’s behalf.
At this time, the agency is working toward restarting on-site inspections during the week of July 20. However, resuming these inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines established by those state and local governments.
- The agency issued new Emergency Use Authorizations for diagnostic tests developed by:
- The University of California-San Francisco’s Health Clinical Laboratories-UCSF Clinical Labs at China Basin (for its molecular-based SARS-CoV-2 RNA DETECTR Assay) and
- BioSewoom, Inc. (for its molecular-based Real-Q 2019-nCoV Detection Kit).
- Testing updates:
- To date, the FDA has currently authorized 173 tests under EUAs; these include 144 molecular tests, 27 antibody tests, and 2 antigen tests.
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