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Washington Marriott Hotel

Apr 15, 2013 8:30 AM - Apr 17, 2013 12:00 PM

1221 22nd Street NW, , Washington, DC 20037-1294 , USA

CMC Workshop: From Drug Development to Global Supply to Patients

Session 4A: Drug Shortages

Session Chair(s)

Norman  Schmuff, PhD

Norman Schmuff, PhD

Associate Director for Science, OPMA, OPQ

FDA, United States

Drug and other medical product shortages have the potential to adversely affect patient care by delaying treatment or forcing the use of second-choice products. Some recent shortages have involved drugs for life-threatening conditions and, in some cases, the product in shortage has been the only product for the patient’s condition. This is a significant public health problem, one that deserves the concerted attention of government and industry. In this session causes, consequences, and FDA action to address and prevent drug shortages will be discussed.

Speaker(s)

Erin  Fox, PharmD

Current Trends in Drug Shortages -- A University of Utah Drug Information Perspective

Erin Fox, PharmD

University of Utah Health Care, United States

Senior Pharmacy Director

Valerie  Jensen, RPh

FDA's Role in Mitigating Drug Shortages

Valerie Jensen, RPh

FDA, United States

Associate Director, CDER Drug Shortage Program

Marta E. Wosinska, PhD

Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages

Marta E. Wosinska, PhD

The Brookings Institution, United States

Visiting Fellow

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