Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Meeting on November 2, 2011, from 8 a.m. to 3:30 p.m.
Agenda: On November 2, 2011, the subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/ pharmacodynamic studies to support a pediatric indication for anticoagulants.
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