Weekly Roundup

Heat.  Humidity.  Storm.  Repeat.

One forecast for tomorrow here in Washington has the temperature reaching 106 degrees. Perhaps the best thing one can do is stay indoors and have a cool drink handy.  If one can be bothered to think about anything else in this heat, here are a few items for the Roundup:

  • FDA Proposes Unique ID System for Medical Devices – The agency announced this week a proposed new rule that would apply a unique identifier number for medical devices along with a production identifier with the aim of enhancing the ability to track and trace adverse events associated with their use.  FDA said it would phase in the approach focusing first on highest risk devices and eventually rolling over to include devices with lesser risk.
  • FDA Approves OraQuick for Home HIV Testing – Later this month the International AIDS Society will hold its newest developments in the battle against HIV/AIDS will be this week’s approval of an over-the-counter home HIV test kit. Long sought after, the concept of home testing does increase access to testing for those who may be at risk and not otherwise seeking testing.  The test will screen for both HIV-1 and HIV-2 and the results will be available to a consumer within minutes of taking it. According to the manufacturer, the test is expected to be in stores in October of this year.
  • OPDP Adds New NOV Letters - This week the Office of Prescription Drug Promotion added a few letters to the batch already up for this year bringing the total so far for the first half of the year to 15. Look next week for the Warning and NOV Letter update here at Eye on FDA for the second quarter of the year.

That’s it for me this week.  Stay cool.

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