Pediatric rule
This article was originally published in The Tan Sheet
Executive Summary
FDA draft guidance on pediatric rule compliance slated for publication in Dec. 4 Federal Register. Published in December 1998, the rule requires that pediatric assessments be included in all NDAs, as well as ANDAs based on suitability petitions for a change in active ingredient, dosage form or route of administration, that are filed after Dec. 2. Although the guidance does not address ANDA suitability petitions, it provides an overview of pediatric assessments, describes waiver/deferral procedures and discusses interactions between the rule and FDAMA pediatric exclusivity requirements