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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In admitting problems, the FDA creates a docket for comments and will convene a public workshop in the spring on why the clinical trial innovation is not more widespread.
The group is intended to help rare disease drug developers answer all the necessary questions about surrogate endpoints and markers before the application review cycle.
In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do more to publicize the experience to date with RWE in regulatory submissions.