FDA Crafts Guidance for Complying With Pediatric Research Equity Act

Drug Industry Daily
KEYWORDS FDA / Guidances

The FDA released draft guidance late last week on how to comply with the Pediatric Research Equity Act, which was signed into law Dec. 3, 2003, and requires new drug applications (NDAs) and biologics licensing applications (BLAs) to contain a pediatric assessment unless a waiver or deferral has been approved by the FDA.

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