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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Heart Failure Drug Development Might Need A Good Lawyer After US FDA Guidance
With draft guidance allowing for drugs that improve heart failure symptoms but do not improve – or may even decrease – survival, the legal community could help establish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.
New Acting US FDA Commissioner Shares Agency's Clinical Trial Reform Message
Norman Sharpless, director of the National Cancer Institute, will become acting FDA commissioner when Scott Gottlieb departs.