OFFICE OF NEW DRUGS MODULE

FAQ

1. Are there other countries that focus on pediatric patients and their needs?
   1. Many trials are international now, and a number of pediatric conditions have small patient populations to study. FDA's goal is to improve coordination with other countries. FDA works closely with the European Medicines Agency (EMA) to share information and to ensure that children are not involved in clinical trials unless such trials are absolutely necessary for a particular indication. Canada and Japan are also engaged with FDA on pediatric matters.
2. Since one of the guidelines for pediatric product development is that it should not delay adult studies or adult availability, can a patent be extended based on pediatric studies?

   1. The patents cannot be extended. PREA does not apply to patents. If PREA is mandated, the company must perform the pediatric studies.

      If a drug is ready for approval in the adult population, FDA will approve that drug for adult patients -- even if the company has not completed all pediatric studies. However, if a drug is being developed primarily for a pediatric condition, FDA will not necessarily approve that drug for use in adults prior to the completion of pediatric studies.