Evolution In Clinical Outcome Assessments Reflected In US FDA’s Revised Gastroparesis Guidance
Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.
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Keeping Track Of US FDA Decisions: COVID-Induced Complete Response Letter For Contepo; Safety Sinks Abicipar Pegol; Approvals For Fintepla and Gimoti
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Targets Migraine, Schizophrenia And Opioid Sparing Drugs For Clinical Outcome Assessment Development
Grant solicitation, a different approach than agency has so far taken with biomarkers, signals growing importance of patient input in drug development.