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Growth Spurt: Pediatric Labeling Is On The Rise, Taxing US FDA Safety Monitoring

 
• By Bridget Silverman

The US FDA Pediatric Advisory Committee uses web-posted reviews of “low safety risk” products to keep up with postmarketing monitoring requirements amid rising interest in pediatric development.

pediatrics
Pediatric safety labeling changes continue to grow. • Source: Shutterstock

Using a streamlined process to fulfill its legislative obligation, the US Food and Drug Administration’s Pediatric Advisory Committee declared routine, ongoing postmarket safety monitoring appropriate for 35 drug and biologic products.

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