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Pediatric Exclusivity Studies Will Be Included In Labeling, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is in the process of developing a policy for including results from studies conducted under the Best Pharmaceuticals for Children Act in labeling, Office of Medical Policy Director Temple says during House hearing on antidepressants.

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FDA Adding More Pediatric Data To Labeling

FDA divisions will be more aggressive in requiring pediatric data be included in labeling following recommendation by Office of New Drugs Director Jenkins. However, the added language in labeling will not necessarily clarify whether a drug is safe for use in children, Office of Pediatric Therapeutics Director Murphy notes.

FDA Adding More Pediatric Data To Labeling

FDA divisions will be more aggressive in requiring pediatric data be included in labeling following recommendation by Office of New Drugs Director Jenkins. However, the added language in labeling will not necessarily clarify whether a drug is safe for use in children, Office of Pediatric Therapeutics Director Murphy notes.

Agency Will Request More Voluntary Safety Data Disclosure By Sponsors

Controversy involving pediatric antidepressant use has encouraged FDA to accelerate public release of safety review data, Acting Deputy Commissioner for Policy Sachdev says. A planned partnership with CMS will also allow for better post-marketing safety surveillance.

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