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Home » GRMP Final Guidance Includes Internal Timelines for PDUFA Reviews
GRMP Final Guidance Includes Internal Timelines for PDUFA Reviews
March 30, 2005
The FDA has revamped its guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products to include specific timelines for application review milestones -- a change that should come as good news to drug manufacturers, many of which criticized the initial version of the document for being too vague.