> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Complex ANDA Product Meetings
- URL: https://www.fdaweb.com/guide-on-complex-anda-product-meetings/
- Published: 2020-11-25T12:00:00.000Z
- Updated: 2026-09-14T16:38:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148167

*Federal Register* notice: FDA has made available a final guidance entitled *Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA*. The document describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an ANDA for a complex product. It provides information on requesting and conducting product development meetings, presubmission meetings, and midreview cycle meetings with the agency.