US FDA’s Stein ‘Excited’ About Real-World Evidence, Rare Disease Endpoint Pilot Programs
Head of Office of New Drugs highlights programs being established under PDUFA VII that could help overcome obstacles in drug development.
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Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.