US FDA Expands Patient Input To New Area: Orphan Grant Applications
Executive SummaryPatient experience will be incorporated into agency orphan grant reviews, and outside rare disease experts will help make decisions.
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US FDA Targets Migraine, Schizophrenia And Opioid Sparing Drugs For Clinical Outcome Assessment Development
Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.