US FDA's Sentinel To Begin Expansion This Fall
Contracts for up to $220m to develop three new Sentinel centers will be awarded in September.
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Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
PDUFA VII Talks Begin With Similar Goals For Industry, US FDA
Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.
Sentinel Study Transparency: FDA Tells Sponsors To Watch Journals, Conferences, Its Website For Results
MaPP indicates limited circumstances when Office of Surveillance and Epidemiology will tell a sponsor about the release of Sentinel safety study results.