> ## 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.

# Office of New Drugs RTF MAPP
- URL: https://www.fdaweb.com/office-of-new-drugs-rtf-mapp/
- Published: 2025-10-23T12:00:00.000Z
- Updated: 2026-09-14T15:24:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160096

The CDER Office of New Drugs has published a Manual of Policies and Procedures (MAPP) with the policies, responsibilities, and procedures for CDER staff to follow when determining whether there is a basis to refuse to file (RTF) an NDA, sNDA, BLA, or sBLA submitted to the Center. The [document](https://www.fda.gov/media/87035/download?ref=fdaweb.com) says it is consistent with information in a 2017 draft guidance and existing policies and procedures, and is intended to provide additional clarification about the RTF process to CDER staff.

The MAPP focuses on CDER policy for refusing to file an NDA under regulations that describe the required content of an application that, if not included in the application, can lead to an RTF action.