What is the purpose of a 120-day safety report?

The purpose of a 120-day safety report is to amend a New Drug Application (NDA) with a safety update. This report serves as a critical mechanism for drug manufacturers to promptly communicate new safety information to the Food and Drug Administration (FDA) regarding drug-related adverse effects that may arise during clinical trials or after a product is marketed. The submission of this report allows the FDA to assess ongoing risks associated with a drug and make informed decisions about approvals and labeling.

Including safety data in the NDA is essential for the FDA's evaluation of the drug's benefits versus its risks. When new or significant safety information becomes available after the initial filing of the NDA, timely updates are necessary to reflect this in the regulatory submission, thereby ensuring that health care providers and patients are aware of these changes.

This 120-day safety report is particularly relevant at a time when patient safety is a top priority for regulatory agencies and underscores the importance of continuous monitoring of product safety post-approval.