Advancing innovations that speed development and approval of safe and effective drugs is a key U.S. Food and Drug Administration mandate. FDA staff identify potential innovations through complex analyses of a vast reservoir of drug and regulatory data. However, getting these data required submission of detailed query requests supplemented by manual searches for data in paper sources—a process that often took weeks to months. Recognizing this substantial inefficiency, FDA tasked ERG with developing an IT-based solution.
ERG interviewed FDA staff to understand their analytical processes and data needs. We then analyzed drug data sources and defined the data fields essential to researching drug development, review, and approval. Based on this analysis, we designed, developed, and populated a database—the Data Analysis and Search Host, or DASH—to serve as a single consolidated source of accurate, verified data. Thanks to DASH, FDA researchers can now run drug development and review queries in minutes instead of months. Results from DASH queries inform FDA and drug sponsors on approaches to speed drug development and approval and are published in journals and included in reports to Congress. Since the launch, ERG has continued to support FDA in expanding and refining DASH to realize further efficiencies and accommodate the growing number of users.