PDUFA VII Could Increase Transparency Of REMS Release Process
Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.
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PDUFA VII Will Fund Pregnancy Postmarket Safety Update, Sentinel Upgrades, REMS Standardization
US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.
PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
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.