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