Literature and Data Resources

The Best Pharmaceuticals for Children Act (BPCA) directs the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health (NICHD,NIH) and the U.S. Food and Drug Administration (FDA), through the off-patent Written Request (WR) process, to review available literature and, when appropriate, to publish Requests for Proposals (RFPs) to conduct needed preclinical studies and clinical trials in children for selected older drugs already approved and marketed for adults.

By sponsoring pharmacoepidemiology studies, literature reviews, and preclinical and pediatric clinical trials, NICHD is improving pediatric therapeutics by increasing scientific knowledge of the frequency of conditions and the frequency of drug use in the pediatric population.

The purpose of this section is to explain the process of WR issued from FDA to NICHD, and to provide data that NICHD has received from ongoing contracts and clinical studies.