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Home » FDA TO STREAMLINE DRUG REVIEW PROCESS WITH 'COMPLETE RESPONSE' LETTERS
FDA TO STREAMLINE DRUG REVIEW PROCESS WITH 'COMPLETE RESPONSE' LETTERS
July 23, 2004
The FDA will use new “complete response” letters, instead of approvable letters or not-approvable letters, to indicate that the review cycle for new and generic drugs is complete but that the applications are not ready for marketing approval, the agency said last week.