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.
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Contracts for up to $220m to develop three new Sentinel centers will be awarded in September.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.