GDF2026 - Pre-Abbreviated New Drug Application (ANDA) Meetings for Complex Drug Products
Agency presentation (regulatory guidance) · July 30, 2026
Agency official delivered a 20-minute presentation explaining how to use FDA pre-meeting pathways (PSG, controlled correspondence, formal PDEV and pre-submission meetings) for complex generic drug products, examples of complexity, meeting-package requirements, timelines (14/30/120 days), and do's and don'ts for applicants.
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