Case Study: U.S. FDA Center for Drug Evaluation and Research (FDA CDER) achieves a single source of truth and faster, more predictable product reviews with Informatica

FDA CDER - Customer Case Study

The FDA’s Center for Drug Evaluation and Research (CDER) needed clearer, faster insight into the lifecycle of every regulated product amid growing globalization, regulatory complexity, and massive data volumes—over 150,000 submissions, 80,000 firms, and millions of adverse-event reports—so it could ensure product safety, manage supply‑chain shortfalls, and improve tracking and reporting across the agency.

CDER built a centralized, modern data platform using Informatica PowerCenter and Master Data Management, an Oracle data warehouse, and a secure B2B exchange to integrate tens of thousands of facilities, entities, and products into a single source of truth. The result: streamlined electronic submissions, faster and more predictable reviews, better collaboration and transparency across stakeholders, and measurable operational efficiencies in regulatory operations.

FDA CDER