Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?
Agency IQ
MAY 17, 2024
How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,
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