> ## 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.

# Proprietary Name Review MAPP
- URL: https://www.fdaweb.com/proprietary-name-review-mapp/
- Published: 2024-08-13T12:00:00.000Z
- Updated: 2026-09-14T14:38:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157560

CDER has issued a Manual of Policies and Procedures (MAPP), *Procedures for Handling Requests for Proprietary Name Review*, with procedures to be used by the CDER Office of Surveillance and Epidemiology (OSE), the Office of New Drugs (OND), the Office of Generic Drugs (OGD), and the Office of Prescription Drug Promotion (OPDP) to handle requests for proprietary name review that may be submitted to INDs, NDAs, BLAs, efficacy supplements, labeling supplements, or ANDAs. The [MAPP](https://www.fda.gov/media/77552/download?ref=fdaweb.com) says OSE will manage the review of proprietary names and will lead an interdisciplinary review team including OND, OPDP, and other CDER offices as relevant in the review of proposed proprietary names.

Other provisions are that:

- OSE will ensure that discussions and decisions for review of proprietary name requests will be made following CDER policy on equal voice, differing professional opinions, and, if necessary, dispute resolution;
- OSE staff will notify application holders about the acceptance or non-acceptance of proposed proprietary names within specified time frames;
- OSE will have the lead responsibility for communicating with industry about CDER review of proposed proprietary names; and
- where notification about acceptance or non-acceptance of a proposed proprietary name is performed in conjunction with other regulatory actions for which delegated authority is not with OSE, OND will include recommendations and decisions from OSE in the letters.