PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers
Industry and FDA agreed to a recommendation package for the PDUFA V commitment letter after dividing agency proposals into three tiers and funding two.
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PDUFA VI: Innovative Trial Design Proposal Includes Modeling, Simulation
Both ideas also will require more FDA expertise, agency tells industry.
PDUFA VI: FDA Proposes Expanding Sentinel, Real-World Safety Data Sources
Growth of post-market surveillance system also may require more resources.
Biomarkers: FDA Working To Define 'Reasonably Likely To Predict' Standard
CDER Director Woodcock says agency should write down its definition of a surrogate endpoint, but industry and academics will have to help with requirements for biomarker approval.