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Home » FDA MULLS CHANGES TO REVIEW PROCESS FOR DRUG APPLICATIONS
FDA MULLS CHANGES TO REVIEW PROCESS FOR DRUG APPLICATIONS
July 19, 2004
The FDA intends to discontinue the use of approvable letters and not-approvable letters for drug marketing applications and instead use “complete response letters” to indicate the review cycle is complete but the application is not ready for approval, the agency announced yesterday.