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.
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Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.
With draft guidance allowing for drugs that improve heart failure symptoms but do not improve – or may even decrease – survival, the legal community could help establish development metrics.
Norman Sharpless, director of the National Cancer Institute, will become acting FDA commissioner when Scott Gottlieb departs.