Today, the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is announcing the establishment of the Newly Identified Safety Signal (NISS) process and the posting of its associated manual of policies and procedures (MAPP) 4121.3, Collaborative Identification, Evaluation, and Resolution of a NISS. FDA makes MAPPs publicly available as part of its transparency effort.

Ensuring the safety of marketed drug products is a critical part of CDER’s mission. The MAPP explains how Center staff collaborate as they work to track, manage, and resolve both clinical- and quality-related safety signals for marketed drugs that meet the NISS criteria.

The Center has been working on multiple fronts to strengthen its safety management activities. The finalization of the process described in the NISS MAPP and the building of an information technology (IT) tool to support the process, the Lifecycle Signal Tracker (LiST), have been critical activities. They are the result of extensive engagement across CDER over multiple years.

The NISS MAPP and LiST not only support CDER’s commitment to drug safety, but also its commitment under Prescription Drug User Fee Act (PDUFA) VI for timely and effective evaluation and communication of postmarket safety. The MAPP and LiST also address recommendations made by the General Accountability Office in its 2015 report DRUG SAFETY — FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement.

The Drug Risk Management Board, announced last January, will ensure CDER’s adoption and adherence to the NISS process. The Board is a unified Center-level body that will ensure seamless alignment for marketed product safety activities among offices.

Any questions on the NISS process or on other CDER safety-focused work, including the DRMB, should be sent to druginfo@fda.hhs.gov.