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
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The FDA’s Pediatric Advisory Committee uses a streamlined web-posted review process to deal with large numbers of “low safety risk” pediatric products.
Prior to an 18 September meeting, committee members reviewed the FDA’s assessment that the postmarketing monitoring for each product did...