Sample Case #4

Q. A sponsor submits an application for a disease that is not generally thought to exist in children. The disease, however, is not one of the conditions that automatically generates a waiver. Can the sponsor get a waiver from having to comply with the 1998 Pediatric Rule anyway?

Q. A sponsor submits an application for a disease that is not generally thought to exist in children. The disease, however, is not one of the conditions that automatically generates a waiver. Can the sponsor get a waiver from having to comply with the 1998 Pediatric Rule anyway?