Glossary

Complete Response Letter

[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated application that must be satisfactorily addressed before it can be approved. NOTE: The use of the Complete Response Letter discontinues FDA’s use of approvable letters and not approvable letters when taking action on marketing applications.

Source: 21 CFR 314.3(b)

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Glossary

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