Recon: FDA declines to approve Eli Lilly eczema therapy over issues with contract manufacturer; Japan’s PMDA plans US office
ReconJason ScottAdvanced therapies/cell and gene therapyAdvertising, Promotion and LabelingAfricaAPIsAsiaAudit/inspectionBiologics/ biosimilars/ vaccinesBiotechnologyCanadaChemistry, Manufacturing and Controls (CMC)Clinical TrialsCombination products/companion diagnosticsComplianceCosmeticsDiagnostics/IVDsDigital health/SaMD/AIEnvironmentalEthicsEuropeGenericsGlobalHealth Authority meeting and communication strategyLatin America/CaribbeanMedical DevicesMiddle EastNorth AmericaNutritional/Natural HealthOceaniaOTCOtherPharmaceuticalsPharmacovigilancePreclinical studyProduct developmentProduct LifecycleProfessional Development/TrainingProject managementQuality Assurance and ControlRegulatory Intelligence/PolicyRegulatory writing/documentationResearch, Design and DevelopmentRisk managementSupply Chain ManagementUnited States