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# Development, Pre-Submission Meeting MAPP
- URL: https://www.fdaweb.com/development-pre-submission-meeting-mapp/
- Published: 2019-09-18T12:00:00.000Z
- Updated: 2026-09-15T01:50:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145027

CDER has issued a Manual of Policies and Procedures (MAPP) outlining the policies and procedures of the Office of Generic Drugs and Office of Pharmaceutical Quality for **(1)** evaluating requests from prospective ANDA applicants for a product development or pre-submission pre-ANDA meeting; and **(2)** conducting such meetings. Under GDUFA 2, the [MAPP](https://www.fda.gov/media/130874/download?ref=fdaweb.com) says, FDA committed to establishing a program to, among other things, clarify regulatory expectations for prospective applicants and assist the applicants to develop more complete ANDA submissions.

As part of that commitment, it agreed to conduct a series of meetings with prospective applicants within specific time frames. CDER says meetings relevant to the MAPP include both product development meetings and pre-submission meetings that are intended to allow prospective applicants to discuss their development of products before they submit an ANDA.

The MAPP includes the agency’s criteria for granting meetings and discusses how its decisions will be communicated.