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FDA Pediatric Advisory Committee (PAC) Meeting | Nov. 13
*The opinions expressed by the hosts and guests in this show are not necessarily the views of Children’s Health Defense.
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*The opinions expressed by the hosts and guests in this show are not necessarily the views of Children’s Health Defense.
‘On November 13, the Pediatric Advisory Committee (PAC) will meet to discuss post-marketing pediatric-focused safety reviews as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109), the Pediatric Research Equity Act of 2003 (Pub. L. 108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (Pub. L. 110-85, title III).
‘The PAC will have the opportunity to ask the Agency clarifying questions and to convey their recommendations for safety monitoring of the products listed below. The scope of the discussion will be limited to post-marketing safety and surveillance activities. No information is required from product sponsors.’
The PAC will meet to discuss the following products listed by FDA Center:
