Pediatric Advisory Committee Meeting

Pediatric Advisory Committee (PAC) · September 16, 2026

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6:12:46

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1:20:00

2:40:00

4:00:00

5:20:00

6:10:00

Welcome and call to order

4:57 → 8:57(4m 1s)

Chair Dr. Pranchan Anay opened the virtual Pediatric Advisory Committee meeting, outlined ground rules for participation, and said the meeting will focus on post‑marketing pediatric safety and surveillance across FDA centers (CDER, CDRH, CBER). He reminded members that discussion is limited to the reviews provided in advance and that the PAC will provide recommendations after Q&A and deliberation.

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Meeting of the FDA Pediatric Advisory Committee (PAC) to review pediatric post‑market safety surveillance across CDER, CDRH and CBER, discuss data‑quality and reporting processes (including the new Report A Problem portal), consider a potential dasatinib–methotrexate interaction and several device and biologics reviews, and vote on continuing routine monitoring and targeted follow‑up.

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No transcript available.