PDUFA Delay: FDA Asks for More Information From Abeona for Pz-cel Market Application
The Dermatology Digest
APRIL 23, 2024
The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel. The BLA for pz-cel was accepted for filing and granted priority review designation by the FDA in November 2023.
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