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This is a revision of this statement posted earlier on September 16.

FDA Statement

Theresa A. Toigo Is Appointed Acting Director of FDA's Office of Women's Health

U.S. Food and Drug Administration Commissioner Lester M. Crawford today announced the appointment of Theresa A. Toigo as the Acting Director of FDA's Office of Women’s Health. Ms. Toigo also serves as the Director of FDA’s Office of Special Health Issues (OSHI).

"Terry brings more than 20 years of exemplary public service mostly as a patient advocate at FDA to this important position," said Dr. Crawford.

The U.S. Food and Drug Administration's Office of Women's Health (OWH) serves as a champion for women's health both within and outside the agency. To achieve its goals, OWH:

• Ensures that FDA functions, both regulatory and oversight remain gender sensitive and responsive;
• Works to correct any identified gender disparities in drug, device and biologics testing, and regulation policy;
• Monitors progress of priority women's health initiatives within FDA;
• Promotes an integrative and interactive approach regarding women's health issues across all the organizational components of the FDA; and
• Forms partnerships with government and non-government entities, including consumer groups, health advocates, professional organizations, and industry, to promote FDA's women's health objectives.

As Director of FDA's Office of Special Health Issues, Ms. Toigo led the office that serves as the agency’s primary liaison with patients and their advocates to encourage and support their active participation in the formulation of FDA regulatory policy. OSHI serves as a channel through which patient issues and viewpoints can be brought to the attention of FDA medical and regulatory staff. OSHI also works with cancer and HIV patients and advocacy programs on issues related to the FDA drug approval process, clinical trials and access to investigational therapies.

Ms. Toigo has held various FDA positions in CDER, CBER and the Office of the Commissioner since joining FDA in 1984. Ms. Toigo has collaborated with the Office of Women’s Health on a variety of FDA initiatives related to the inclusion of women and minorities in clinical trials. Ms. Toigo received her pharmacy (BS) and business (MBA) degrees from Rutgers University.

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