The Committee advises and makes recommendations to the Commissioner of Food and Drugs regarding (1) pediatric research conducted under sections 351, 409I, and 499 of the Public Health Service Act and sections 501, 502, 505, 505A, and 505B of the Federal Food, Drug, and Cosmetic Act; (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions, (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics, (4) pediatric labeling disputes as specified in section 3 of the Best Pharmaceuticals for Children Act (Public Law 107-109), (5) pediatric labeling changes as specified in section 5 of the Best Pharmaceuticals for Children Act (Public Law 107-109), (6) adverse event reports for drugs granted-pediatric exclusivity and any safety issues that may occur as specified in section 17 of the Best Pharmaceuticals for Children Act (Public Law 107-109), (7) any other pediatric issue or pediatric labeling dispute involving FDA-regulated products, (8) research involving children as subjects as specified in 21 CFR 50.54, and (9) any other matter involving pediatrics for which FDA has regulatory responsibility.
The Committee shall consist of a core of 14 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. The core of voting members shall also include one representative from a relevant patient or patient-family organization and may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests and one non-voting member who represents a pediatric health organization.
Walter Ellenberg, PhD, Designated Federal Official
Office of Pediatric Therapeutics
Office of the Commissioner
Building 32, Room 5154
10903 New Hampshire Ave.
Silver Spring, Maryland 20993
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