ARTICLE | Politics, Policy & Law
FDA's pediatric drug list
March 16, 1998 8:00 AM UTC
WASHINGTON - The FDA has released a draft list of approved drugs for which additional studies or information could result in improved pediatric health care.
FDA said the list is not a request to conduct pediatric trials, nor does being on the list mean that a drug is entitled to pediatric exclusivity under provisions of the FDA reform law. Under the new law, under certain circumstances, sponsors of additional pediatric studies will be eligible for an additional six months of market exclusivity for the pediatric indication...