USA – CDER releases policy for handling newly identified safety signals

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) last week issued a new manual of policies and procedures (MAPP) explaining its internal process for identifying, evaluating and resolving newly identified safety signals (NISS) for marketed drugs.

FDA says the MAPP is meant to provide a “high level” overview of how and when communication related to newly identified safety issues is transmitted between different offices and disciplines within CDER. The MAPP applies to safety signals related to approved drugs and biologics, marketed yet unapproved drugs, over-the-counter monograph products, compounded drugs and medical gases.

FDA explains that NISS are serious adverse events, medication errors or adverse events that suggest therapeutic inequivalence or quality issues that warrant further investigation. 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…