FDA to resume on-site inspections in U.S.

Jul. 10, 2020 12:43 PM ETHealth Care Select Sector SPDR (XLV), XBI, PJP, IHE, XPH, VHT, IBB, IHIIBB, XLV, VHT, PJP, XBI, IHE, IHI, XPHBy: Douglas W. House, SA News Editor1 Comment
  • The FDA intents to restart on-site inspections in the U.S., shut down in March due to the COVID-19 pandemic, the week of July 20.
  • Inspections will be prioritized according to a rating system based on real-time state and national data to assess the number of COVID-19 cases in a given area. The system will generate an "advisory level" based on the outcome of three metrics: phase of the particular state and county-level statistics on the current trend and intensity of infections.
  • County-level "advisories" will be parsed as: mission-critical inspections only, all inspections with caveats to help protect staff and resumption of all regulatory activities.
  • Inspections will be pre-announced to ensure the safety of all concerned with the exception of retail tobacco sites since they are undercover operations.
  • The agency says it will need to see a downward trend in new cases before upgrading an area to a less-stringent level.
  • Selected tickers: XLV, XBI, PJP, IHE, XPH, VHT, IBB, IHI

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