Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When
Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.
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US FDA’s Real-Time Oncology Review Program Is No Guarantee For Early Approval
Early approvals may not be feasible for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.
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.