The US Food and Drug Administration (FDA) may need greater authority to require pediatric clinical studies for drugs, including orphan drugs, according to a recent research letter published in JAMA Pediatrics.
While the Pediatric Research Equity Act (PREA) grants FDA the authority to require drugmakers to conduct pediatric studies for certain drugs that are approved for adults, most orphan indications are exempt from this requirement, which the authors of the letter say restricts public understanding of how these treatments affect children…
