Request for Nominations of Specific Drug/Biologic Product(s) That Could Be Brought Before the Food and Drug Administration's Pediatric Subcommittee of the Oncologic Drugs Advisory Committee

摘要

The Food and Drug Administration's (FDA) Office of Hematology and Oncology Products invites the public to suggest one or more specific drug or biologic products that could be brought before the December 4, 2012, Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (ODAC). The number of drugs studied for use in pediatric patients is growing, and we see a reduction in off-label use. However, we would like to improve current and future pediatric product development by focusing on products whose development would benefit the most from the attention of an advisory committee. The company developing a product that is brought before the committee will be given the unique opportunity to present proposed pediatric studies in the United States, share their plans for global pediatric development, and hear discussions by the Pediatric Subcommittee on possible directions for their current or future pediatric oncology product development.