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The FDA's formal 'not yet' to a drug application, listing what must be fixed before approval: more data, a different trial population, or manufacturing problems. Not the same as 'complete response' to treatment.
A CRL ends a review cycle without approval; the sponsor can resubmit (class 1 or 2, with 2- or 6-month review clocks), appeal, or abandon. Reasons in oncology have included trials run only in China without US-relevant populations (sintilimab, camrelizumab-rivoceranib), inadequate confirmatory data for a population, unresolved safety signals, and manufacturing site inspection failures, which caused a wave of CRLs in 2022-25. The FDA began publishing CRLs in 2025. The EMA equivalent is a negative CHMP opinion or a withdrawal of the application before opinion.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Confirmatory trial.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares ODAC (Oncologic Drugs Advisory Committee), Confirmatory trial.
Shares Confirmatory trial, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares ODAC (Oncologic Drugs Advisory Committee), Confirmatory trial.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Confirmatory trial, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares Confirmatory trial, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).