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- EMA seeks industry input on draft guideline for biomarker-guided therapy approvalsThe European Medicines Agency has published a draft guideline that details the information required for approving medicines that use biomarkers to select patients. The agency is opening a public c…
- FDA asks industry for feedback on improving patient-level real-world data submissionsThe FDA announced a request for comments on ways to address challenges associated with submitting patient-level real-world data and evidence in drug and biologic applications. The agency is seekin…