OFFICE OF NEW DRUGS MODULE

• The plan for deferred studies must include a statement of intent that outlines the pediatric assessment that the sponsor plans to conduct. It should address development of an age-appropriate formulation, and it must outline when the protocols will be submitted, when the studies will be completed and when the submission of final study reports will occur.
• Establishes the Pediatric Review Committee to review pediatric plans and assessments, and waiver and deferral requests.

PREA mandates that the sponsor submit an annual summary of progress for all their deferred studies. After regulatory action has been taken, the medical, statistical and pharmacology reviews are posted on FDA's Website.