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Rear Admiral Sandra L. Kweder, M.D.
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Rear Admiral Sandra L. Kweder graduated from the University of Connecticut in 1979 and attended the University of North Carolina's School of Public Health in Chapel Hill. She was commissioned in the U.S. Public Health Service in 1980 upon entering the Uniformed Services University of Health Sciences (USUHS). She was awarded her M.D. in 1984, along with the Surgeon General's Award for Outstanding PHS Graduate. She completed her internship and residency in Internal Medicine at the Walter Reed Army Medical Center, where she also was the Chief Resident. She is certified by the American Board of Internal Medicine.

In 1988 RADM Kweder joined the U.S. Food & Drug Administration (FDA) as a medical reviewer in the Division of Antiviral Drugs, to address the growing field of HIV drug development. She has since held a number of positions, including leadership of the Division of Postmarketing Surveillance & Epidemiology and the Office of Antimicrobial Products and spent two years on sabbatical at Brown University as a clinical fellow in Obstetric and Consultative Medicine. She has been Deputy Director, Office of New Drugs (OND) in FDA's Center for Drug Evaluation & Research (CDER) since 2002.

As Deputy Director RADM Kweder supports the Director's oversight of over 700 scientific professionals, charged with ensuring the safety and effectiveness of all investigational and marketed drugs in the United States, and shares leadership of activities such as a large OND reorganization in 2005 that also integrated biological therapeutics into CDER. She co-chairs OND's Change Coordination Group, which brings a new paradigm to directing and integrating initiatives to build scientifically sound processes and shared responsibility across CDER, such as monitoring postmarketing safety of drugs, holding effective industry meetings and standard setting in the review of product applications. RADM Kweder also oversees the Pediatric and Maternal Health staff in CDER which, among other expert pediatric activities, implements the Best Pharmaceuticals for Children Act and provides direction across the Agency on labeling products for safe use in pregnancy and lactation. She oversees the Study Endpoints and Labeling Development team in building the science of endpoint assessment in clinical trials and coordinating numerous drug labeling activities for all of CDER. RADM Kweder frequently represents FDA in academic and professional settings, meetings with consumer and patient advocacy groups, regulated industry and the press. She has represented the Agency in Senate and Congressional Hearings. She is an Associate Professor of Medicine at USUHS and continues to practice clinical medicine and teach there and at the National Naval Medical Center. As a member of the Commissioned Corps of the U.S. Public Health Service, RADM Kweder was deployed to Baton Rouge, LA, in September 2005 for Hurricane Katrina. She has been the recipient of many awards and honors, including the PHS Outstanding Service Medal and two PHS Meritorious Service Medals.


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