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Pharmaxi
Table of ContentsIntroductionOverview of Regulatory Challenges in Clinical TrialsRegulatory Processes in the European UnionHarmonized ApproachSingle Submission PortalParallel AssessmentRisk-Based ApproachRegulatory Processes in the United StatesFDA OversightIND ApplicationSequential EvaluationStringent MonitoringEmphasizing the Ease of Conducting Trials in the EUFaster Approval TimelinesReduced Administrative BurdenFacilitated Multinational TrialsConclusionComparative Analysis of EU and US Regulatory EnvironmentsFAQsHow does the EU's... more
Pharmaxi Dec 29 '23 · Tags: cro