complete response letter
- Guideline or reference source
- FDAGDUFA Generic Drug User Fee Amendments 2012
- Definition
- a written communication to an applicant or DMF holder from FDA usually describing all of the deficiencies that the agency has identified in an abbreviated application (including pending amendments) or a 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. Refer to 21 CFR 314.110 and http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084138.htm1 for additional details. When a citizen petition may impact the approvability of the ANDA, FDA will strive to address, where possible, valid issues raised in a relevant citizen petition in the complete response letter. If a citizen petition raises an issue that would delay only part of a complete response, a response that addresses all other issues will be considered a complete response.
- Related Term
- act on application
- first major deficiency application
- solicited amendment
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