The Pediatric Research Equity Act (PREA)—requiring drug makers to test all drugs for safety and efficacy in pediatric populations as well as in adults—was passed in 2003 and updated in 2007. And in Europe, a similar requirement has been in effect since 2007.
Tag: pediatric requirements
New Survey Reveals Companies’ Concerns About Too Few Pediatric Patients for Clinical Trials Premier Research’s Survey Also Reveals Confusion About PREA and Its EU Counterpart
A new biopharma survey of 55 biotech and pharmaceutical firms in both the North America and European markets by Premier Research reveals that the biggest problem those companies are facing in complying with pediatric regulations is that there may not be enough children who are both accessible and can meet often stringent study criteria to participate in the required clinical trials.