COVID-19: FDA Schedules 5 More Virtual Town Halls Through September
The US agency has announced another month of webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the novel coronavirus.
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US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?