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Understanding the PDUFA Date System When drug companies submit a Biologics License Application (BLA) which is what Eli Lilly will file for retatrutide, since it's regulated as a biologic rather than a small-molecule drug the FDA assigns a PDUFA date : Prescription Drug User Fee Act date
NG28 Education chapter
Retatrutide is exciting, but it is still in trials, and its long-term impact remains unknown
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