The Center for Drug Evaluation and Research (CDER) under the U.S. Food and Drug Administration (FDA) released new guidance and manuals that explain the internal process of identifying and evaluating Newly Identified Safety Signals (NISS) for marketed drugs.

According to the FDA, NISS are serious adverse events and medical events which determine further investigations into the process.  NISS also include quality issues that “could negatively affect public health or the benefit-risk profile of a product; and cannot be resolved through existing routine processes,” such as recalls or inspection findings.