Complete Response Letter
regulatory action by the US Food and Drug Administration
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. CRLs replaced approvable letters in 2018.
Background
Under the Prescription Drug User Fee Act, the Food and Drug Administration has a limited timespan (known as the PDUFA date) to decide a New Drug Application, Abbreviated New Drug Application or Biologics License Application. The FDA may either approve the application or issue a Complete Response Letter. Grounds behind issuing a CRL may include labeling issues, current Good Manufacturing Practice concerns or concerns about the safety or effectiveness of the drug.
A sponsor receiving CRL may withdraw the application, request a hearing or resubmit the application. Because hearings are open to the public, this course of action is relatively rarely chosen.
Class 1 and Class 2 resubmissions after CRLs
MAPP 6020 Rev. 2, the Food and Drug Administration policy manual governing resubmissions following a CRL, classifies CRLs as requiring a Class 1 or Class 2 resubmission. Where a sponsor decides to submit a response to a CRL, the response is classified within 30 days, if the response is complete.
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This entry incorporates text from “Complete Response Letter” on English Wikipedia. Contributors are listed in the page history. Text is available under the Creative Commons Attribution-ShareAlike 4.0 License. Selected authority identifiers and statements are retrieved from Wikidata under CC0; their references and qualifiers remain part of the verification path.