Deleted Tweet from Scott Gottlieb, R-D.C.
Deleted Tweet from Scott Gottlieb, M.D.
SteveFDA (R-D.C.)
@SGottliebFDA
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@SarahKarlin For PDUFA-related products FDA will accept and work on new regulatory submissions for which no fee is required. These include INDs. But for not user-fee related products we can't perform work on an IND unless it's excepted activity such as an emergency IND (compassionate use IND)
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