Combo Product Firms Want Simpler Adverse Event Reporting Structure
This article was originally published in The Gray Sheet
Executive SummaryFDA's proposed adverse event reporting requirements for combination products should be rewritten to simplify the way events are reported when multiple manufacturers are involved, firms say
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FDA’s prescription drug regulations in the works include rules on generic drug labeling, compounding, bioequivalence reports and safety reporting for combination products.
FDA has yet to prognosticate on a schedule for other FDASIA-mandated regulations; HHS says that FDA’s priorities for the coming year will involve devices and food, as well as promoting international regulatory cooperation.