CRL
The FDA notification that an NDA or BLA cannot be approved in its present form.
Definition
A Complete Response Letter (CRL) is the FDA's formal communication that it cannot approve an NDA or BLA without further information or changes. The CRL itself is confidential; sponsors choose how much detail to disclose publicly. Common CRL triggers: GMP/manufacturing inspection failures, unresolved safety signals, label disputes, additional efficacy data required. Stock-price impact often -15% to -40% on the day.
See also
- NDA — New Drug Application — the FDA submission required to market a new small-molecule drug in the US.
- BLA — Biologics License Application — the FDA submission required for biologics (proteins, antibodies, gene therapies).
- PDUFA date — The FDA target action date for an NDA or BLA, set under the Prescription Drug User Fee Act.