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# ANDA Complex Product Meeting Guidance
- URL: https://www.fdaweb.com/anda-complex-product-meeting-guidance/
- Published: 2020-11-24T12:00:00.000Z
- Updated: 2026-09-14T16:37:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148157

FDA has published a guidance, *Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA*, describing an enhanced pathway for discussions between the agency and applicants for ANDAs for a complex product, as defined in the guidance. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-anda-applicants-complex-products-under-gdufa-guidance-industry?utm%5Fmedium=email&utm%5Fsource=govdelivery) specifically provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA, it says.

The guidance reflects a unified approach to all formal meetings between the agency and ANDA applicants or prospective applicants for complex products, FDA says.

First published as a draft 10/2017, the guidance: 

- defines complex generic drug products for the purposes of the meetings;
- defines meeting types;
- provides related GDUFA 2 performance goals;
- offers recommendations for meeting requests; and
- provides general information on FDA assessment of meeting requests, rescheduling or canceling meetings, meeting package content and submission, pre-meeting communications, the conduct of meetings, and meeting minutes.