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Pediatric Protocol In Written Agreement Should Be Strictly Followed - FDA

This article was originally published in The Tan Sheet

Executive Summary

NDA sponsors will be expected to adhere precisely to study protocols included in written agreements, FDA's revised guidance on pediatric exclusivity states.

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Pediatric study proposals will be prioritized by time of submission, FDA guidance states.

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).

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