Real-Time Post-Market Signal For Enhanced Surveillance

Background
The U.S. Food and Drug Administration (FDA) is conducting market research to understand industry capabilities related to providing real-time or near-real-time signals that may support FDA’s post-market surveillance activities for regulated products.

The FDA's mission includes monitoring the safety, quality, and performance of these products throughout their lifecycle. Existing surveillance systems include initiatives such as the Sentinel Initiative, Biologics Effectiveness and Safety (BEST) Initiative, and various reporting systems for adverse events.

The FDA is exploring whether real-time signals from external sources could enhance existing surveillance efforts by providing earlier awareness of emerging events affecting regulated products.

Work Details
FDA is interested in learning if commercial organizations can provide timely signals or alerts related to events affecting regulated products, including safety events, product quality issues, supply disruptions, and significant public health signals.

The information gathered will assist in determining the availability of industry capabilities, potential technical integration approaches, and possible cost models for providing real-time signal feeds to FDA systems. Signals of interest may include safety events or adverse reactions, product recalls or quality issues, manufacturing disruptions, supply chain shortages, public health alerts, and compliance or regulatory actions.

The FDA seeks to understand how these signals could be delivered through Application Programming Interfaces (APIs) or other automated integration mechanisms.