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User Fees Drug Review Regulation

PDUFA VII Could Expand US Real-Time Review Beyond Oncology

  • Analysis

Executive Summary

A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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