About FDA

Number of Pediatric Advisory Committee (PAC) related activities in the month

Dictionary:
The Office of Pediatric Therapeutics plans and coordinates all aspects of FDA’s Pediatric Advisory Committee (PAC) meetings. This effort includes meeting management, recruitment and maintenance of PAC members and Special Government Employees (SGE) experts, conflict of interest (COI) analysis and logistics.

Pediatric Advisory Committee meetings are announced in the Federal Register and are open to the public, unless otherwise stated. The Pediatric Advisory Committee advises and makes recommendations to the Commissioner of Food and Drugs on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices, pediatric research, pediatric ethical issues and any other matter involving pediatrics for which the Food and Drug Administration has regulatory responsibility. The committees are established to provide functions which support the FDA's mission of protecting and promoting the public health and safety of children.

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.

In advance of each meeting, the Office of Pediatric Therapeutics, in accordance with the Federal Advisory Committee Act, coordinates all aspects of the Pediatric Advisory Committee. This effort includes the recruitment, identification, selection and appointment of well-qualified committee members and consulting experts. In addition, the Office of Pediatric Therapeutics coordinates all logistical matters associated with the meeting (e.g. member availability, travel, lodging, etc).

In order to participate in a meeting, members of the committee and other required experts are screened to identify potential conflicts of interest to all matters to be discussed at the meeting.A Federal employee may not participate personally and substantially in a particular matter in which, to his knowledge, he, his spouse, minor child, general partner, organization in which he is serving as officer, director, trustee, general partner or employee, or any person or organization with whom he is negotiating or has any arrangement concerning prospective employment, has a financial interest.

Information is current as of December 31, 2012.

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