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The letter makes reference to an ongoing review of inspection findings from a third-party filler involved with the drug development. Regeneron will not require additional trial data.

United statesIapocec dianaDavid brownAssociation for researchStanford universityByers eye instituteParty fillerDrug administrationComplete response letterAnnual meetingRetina consultantsFor afliberceptBiologics license application solely dueOngoing reviewInspection findingsPublished june