The RADAR Project and the FDA

Results from the First Decade of Research Conducted by the Research on Adverse Drug Events and Reports (RADAR) Project

“…Over a period of 7 years, RADAR investigated 16 serious ADRs utilizing 25 investigators in parallel with the FDA, which reviewed more than 900,000 reports and contributed to at least 1,500 safety-related labelling changes with the support of a large team of investigators and a multimillion dollar budget. 55 …”

Gathering and Exploring Scientific Knowledge in Pharmacovigilance

“…Large-scale projects such as Research on Adverse Drug Events and Reports (RADAR) [16], Observational Medical Outcomes Partnership (OMOP) , Mini-Sentinel [17] or Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) [18], among others, are pushing forward innovative strategies to improve active pharmacovigilance scenarios.…”