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Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

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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.,

Science 40
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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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