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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.

Key Takeaways

  • The FDA’s Pediatric Advisory Committee uses a streamlined web-posted review process to deal with large numbers of “low safety risk” pediatric products.

  • Since FDAAA was enacted, the number of approved pediatric labeling changes has jumped significantly

Prior to an 18 September meeting, committee members reviewed the FDA’s assessment that the postmarketing monitoring for each product did

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