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US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose

Executive Summary

Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.

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Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion

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PDUFA VII Communications: Earlier PMR Talks, Formal Meeting Additions

Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.

PDUFA VII Could Expand US Real-Time Review Beyond Oncology

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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