Complete Response Letter

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.[1] CRLs replaced approvable letters in 2018.

  1. ^ "21 CFR 314.110". www.accessdata.fda.gov. Archived from the original on November 28, 2002. Retrieved 2021-06-30.
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