PDUFA VII Could Expand US Real-Time Review Beyond Oncology
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.
You may also be interested in...
Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
PDUFA VII Commitment Letter Outlines Real-Time Review Expansion, Hiring Goals
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
Would An Independent Analysis Of US FDA's Pandemic Response Find Transformative Effect?
Group of outside experts could help the agency determine the pandemic-inspired practices and regulatory changes to keep, former commissioner von Eschenbach says.