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FDA hopes to reach a tentative agreement with industry groups on a MDUFA VI user fee reauthorization this month, but the two sides still have multiple issues to resolve, according to public meeting minutes.
In this month's news, Medtronic gets clearance for fast-acting insulin pump, VB Spine to buy SpineHawk, strategic profit forecasts vary, and more.
A MHRA proposal would allow firms to rely on EU MDR/IVDR CE marks indefinitely in Great Britain. Excerpted from Pathways’ Picks February 18: Britain Gives in to the CE Mark, CMS ACCESS Updates, South Korea Wellness Policy.