Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA

5 October 2022 — FDA published final guidance on formal meetings between FDA and ANDA applicants of complex products under generic drug user fee amendments (GDUFA) for industry.

This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) for a complex product, as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, mid-cycle review meetings, enhanced mid-cycle review meetings, and post-complete response letter scientific meetings with FDA.