Dosage forms preapproval inspections

Preapproval inspection has always been part of the FDA s armory of enforcement. Formerly it was commonly used only in connection with newly constructed facilities, or where existing facilities had never been inspected before, or where a period of two years had elapsed since a previous inspection on a similar dosage form. All of these criteria still apply, but all new chemical entities must be preapproved for products currently being distributed, the top 200 are to be inspected for approval, and drugs with a narrow therapeutic range are to be preapproved. 

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