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Home » GRMP Guidance Includes Internal Timelines for PDUFA Reviews
GRMP Guidance Includes Internal Timelines for PDUFA Reviews
April 1, 2005
The FDA’s final guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products now includes specific timelines for application review milestones — a change that will be welcomed by drugmakers, many of which criticized the initial draft document for being too vague.