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In this week’s Pathways Picks: FDA schedules public launch meeting for MDUFA VI talks, and proposes to downclassify a category of companion diagnostics to 510(k) status; Medicare nationally covers respiratory assist devices; Brazil cancels upclassified IVD certifications; China issues guidance on next-generation sequencing classifications; South Korea details consultation procedures; and more.
In this month's news, expanded indication clearances from Intuitive and Element Science; Edwards Lifesciences gets the OK for asymptomatic patients, Safe Life grows its European footprint, and more.
The African Medicines Agency launches. Excerpted from Pathways’ Picks May 28: Global Picks, FDA Guidance Docs, MDUFA Support, and More.