Digital Health In Brief
This article was originally published in The Gray Sheet
Executive SummaryFDA clears wireless fetal monitor
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The FDA’s OPQ touts approval of sixth and seventh continuously manufactured drugs and quicker delivery of inspection results in latest annual report.
No device-related warning letters were released by the US FDA the week of 19 February.
Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.