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Complete Response Letter (CRL)
Complete Response Letter (CRL)
Complete response letter is a written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an abbreviated application (including pending amendments) or a Drug Master File (DMF) that must be satisfactorily addressed before the ANDA can be approved. Complete response letters will reflect a complete review and will require a complete response from industry to restart the clock. This is also applicable to IND/NDA/BLA/MAA and supplements such as CBE-30/PAS.