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Dr. Janet Arrowsmith-Lowe |
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Dr. Janet Arrowsmith-Lowe is a board-certified internist
and CDC trained epidemiologist who served with the Food and Drug
Administration for 14 years. She is a nationally recognized expert in
the regulation of pharmaceuticals, medical devices, and biologics. At
FDA, she served as director of the office responsible for both
postmarket safety surveillance and premarket statistical evaluation of
medical devices in the Center for Devices and Radiological Health. She
was Deputy Director of FDA’s Office of AIDS and Special Concerns
(formerly the AIDS Coordination Staff), and served as a medical reviewer
in both the Center for Drug Evaluation and Research and the Center for
Biologics Evaluation and Research. Dr. Arrowsmith-Lowe has published
more than 25 peer-reviewed articles on postmarket safety issues related
to marketed drugs, devices, and biologic products, as well as authoring
several book chapters on postmarket safety issues with pharmaceuticals.
She is the FDA contributing author to the U S PHS statement on
management of occupational exposure to human immunodeficiency virus
published in the MMWR in 1990. She has served on grant review
panels for the Centers for Disease Control and Prevention’s HIV
community-based outreach programs. Her expertise has been sought by
local, regional and national organizations to serve on advisory boards
and review panels addressing healthcare issues in general and
HIV-related healthcare issues in particular. She has represented local
chapters of the American College of Physicians-American Society for
Internal Medicine and the Commissioned Officers’ Association.
Dr. Arrowsmith-Lowe coordinated the development of the initial HIV clinical care guidelines for the Agency for Healthcare Policy and Research and led the effort to develop the regulations for Medical Device Reporting requirements. She has served on a number of national and international advisory committees addressing AIDS and public health policies. She has received numerous awards for her work in the field of AIDS as well as her research in safety issues of FDA regulated products. Dr. Arrowsmith-Lowe is a Fellow in the American College of Physicians, serves as a peer reviewer for The Annals of Internal Medicine, is a former editor pro tempore of CDC’s Morbidity and Mortality Weekly Report, and maintains a part-time practice in family and internal medicine.
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