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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Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
Group of outside experts could help the agency determine the pandemic-inspired practices and regulatory changes to keep, former commissioner von Eschenbach says.