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The National Evaluation System for health Technology Coordinating Center announced 12 new test cases that use real-world evidence to examine medical device industry priorities. The list includes an Apple Watch study, as well as an FDA proposal on the use of pelvic mesh to treat urinary incontinence.
UK parliament’s indecision over how – or if – to enact Brexit saw the planned March 29 withdrawal deadline come and go. The default positions of the inter-ministerial Office for Lifesciences (OLS) and health-care products regulator (MHRA) are still to prepare for a no-deal exit from the EU.
Donated blood must be tested by blood-collection groups for evidence of infection with Trypanosoma cruzi, a parasite that causes Chagas disease – either for donation purposes or for use in manufacturing a medical device – FDA says in final guidance released Dec. 5.
Keeping Track: US FDA Approvals Of Mavyret, Idhifa, Vyxeos Headline Week Of Breakthroughs, Hematology And Hematology BTDs
The latest drug development news and highlights from our FDA Performance Tracker.
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Miles White, CEO
Thomas D Brown, SVP
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Steve Weger, VP, Strat. Planning & Tech. Assessment
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James J Koziarz, PhD, VP, Diagnostic Products R&D
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