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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The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
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.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.