Pediatric study proposals will be prioritized by time of submission, FDA guidance states.
This article was originally published in The Tan Sheet
Executive Summary
PEDIATRIC DRUG STUDY PROPOSALS WILL BE PRIORITIZED BY TIME OF SUBMISSION and the date of expiry of marketing exclusivity or patent, FDA's June 29 "Qualifying for Pediatric Exclusivity" guidance states. The agency will give top priority review to drugs that lose marketing exclusivity on or before March 31, 1999 if the sponsor submits a proposed pediatric study request by this Aug. 31. The drug must be one of about 490 included in the priority pediatric drug list issued May 20, of which 23 are OTCs ("The Tan Sheet" May 25, p. 12).