Sponsors who base an NDA primarily or solely on clinical trials with enriched populations could face a possible post-market commitment or requirement to better define the drug’s effect in a broader population.
Clinical Trial Enrichment Could Require Post-Market Studies, Labeling To Address Shortcomings
FDA’s guidance on clinical trial enrichment notes that a lack of information on patients without the enrichment characteristic may result in Phase IV studies to characterize a drug’s safety and efficacy in a broader population.
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