During the BPCA process, a drug company submits a proposed pediatric study request. This is a summary of all the studies the company would like to perform to qualify for exclusivity. In addition, FDA can issue a written request without a proposed pediatric study request.
Sometimes, the written request will match what the sponsor has proposed. Many times FDA will require additional studies, e.g., for a different indication or for nonclinical studies. Six months of marketing exclusivity is granted if the terms of the written request are fairly met.
Positive study results are not required for the drug company to receive pediatric exclusivity. If a company does all the studies of a drug for a certain indication, the company may get pediatric exclusivity -- even if efficacy is not demonstrated or a new safety signal is not identified. The information from these studies is included in the labeling.