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# New Safety Signal MAPP
- URL: https://www.fdaweb.com/new-safety-signal-mapp/
- Published: 2020-04-30T12:00:00.000Z
- Updated: 2026-09-14T16:13:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146688

CDER has issued a Manual of Policies and Procedures (MAPP) describing the policies and procedures for collaborative identification, evaluation, and resolution of a newly identified safety signal (NISS) associated with marketed drugs. The MAPP notes that multiple Center offices have roles in identifying, evaluating, and resolving a NISS, depending on the office’s role in CDER and the staff’s expertise.

“This MAPP describes at a high level how and when communication flows from one office or discipline to another,” it says. “More detail can be found in office-specific procedures. This MAPP also describes how CDER’s Incident Management Plan — the process for managing incidents during an existing or potential emergency — converges with the process described in this MAPP.”

CDER says it has been working on multiple fronts to strengthen its safety activities. It says finalization of the process described in the MAPP and building of the Lifecycle Signal Tracker, an information tool to support the process, have been critical activities.