A collaborative scheme between the US Food and Drug Administration and the European Medicines Agency is yet to be embraced by complex generic developers. According to the FDA’s latest update on the parallel scientific advice scheme, only two applicants were granted PSA meetings and have completed the process more than two years after its launch.
FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake
Two Applicants Have Completed The US-EU Parallel Advice Process So Far
While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.
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