U.S. Food and Drug Administration

Office of Pediatric Therapeutics

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Pediatric Ethics Subcommittee

Preamble & Guidance Documents

Pediatric Legislation


BPCA Labeling Changes

PREA Labeling Changes

Safety Reporting

Pediatric Studies Summaries
(June 2003 – January 2008)

Pediatric Studies Full Review
(January 2008 – Present)

Written Request List
(2002 – 2007)

Written Request Documents (FDAAA)
(2007 – Present)

Pediatric Advisory Committee (PAC)

Parents and Children