Science Board to the FDA, Risk Communication, and Pediatrics Vacancies
|Science Board to the Food and Drug Administration|
The Science Board shall provide advice to the Commissioner and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board will provide advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science; and input into the Agency’s research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs.
|Knowledgeable in the fields of food science, safety, and nutrition; chemistry; pharmacology; translational and clinical medicine and research; toxicology; biostatistics; medical devices; imaging; robotics; cell and tissue based products; regenerative medicine; public health and epidemiology; international health and regulation; product safety; product manufacturing sciences and quality; and other scientific areas relevant to FDA regulated products such as systems biology, informatics, nanotechnology, and combination products.||3|
|Risk Communication Advisory Committee||Provide advice to the Commissioner or designee on strategies and programs designed to communicate with the public about the risks and benefits of Food and Drug Administration (FDA)-regulated products so as to facilitate optimal use of these products. The committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products. Duration of this committee is two years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest.||Knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Some members will be selected to provide experiential insight on the communications needs of the various groups who use FDA-regulated products. The latter may include patients and patients' family members, health professional, communicators in health, medicine and science, persons affiliated with consumer, specific disease, or patient safety advocacy groups.||1|
|Pediatrics Advisory Committee||The Committee advises and makes recommendations to the Commissioner of Food and Drugs regarding (1) pediatric research; (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, (5) pediatric labeling changes, (6) adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur, (7) any other pediatric issue or pediatric labeling dispute involving FDA regulated products, (8) research involving children as subjects, and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by the Department of Health and Human Services.||Knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. The core of voting members shall also include one representative from a pediatric health organization and 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.||3|
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