What is a Complete Response Letter (CRL)?
The FDA's rejection letter — the application cannot be approved in its current form.
A CRL lists the deficiencies the sponsor must address, which can range from minor labeling issues to demands for new clinical trials. Some CRLs are effectively deferrals; others kill programs.
The FDA began publishing CRLs directly, but the sponsor's 8-K usually lands first. Terminations and CRLs are the events our change-detection engine is built to catch fastest.
See it live: the catalyst calendar · status-change feed