Among the US Food and Drug Administration’s enormous workload, one task is consuming much more of its time: determining if products qualify for three-year exclusivity when the sponsor conducts a new clinical investigation.
FDA Staff ‘Literally’ Up At Night Deciding 3-Year Exclusivity Requests
More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.
