Pediatric Clinical Trials and FDA PREA Requirements in the United States
Pediatric Clinical Trials and FDA PREA Requirements in the United States Conducting Pediatric Clinical Trials in the U.S.: Navigating FDA PREA Requirements Introduction Pediatric clinical trials present unique ethical, scientific, and regulatory challenges. To address historical gaps in pediatric drug development, the U.S. Congress enacted the Pediatric Research Equity Act (PREA) in 2003, requiring sponsors…
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