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U.S. Department of Health and Human Services

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Office of Women’s Health (OWH) Program Description

 

Goals: The purpose of this rotation is to familiarize the student with the role of the Food and Drug Administration (FDA) in the medical product development and offer more in-depth understanding of the importance of studying sex differences in the efficacy and safety of medical products and the outreach activities by the Office.
The FDA Office of Women's Health (OWH) established its Research and Development Program in 1994 to:
  • address gaps in current scientific knowledge
  • encourage new directions in research
  • set new standards of excellence in women's health.
The OWH Science Program plays an integral role in promoting the scientific understanding of sex and gender differences in disease burden, treatment and response. OWH advocates for the study of sex differences in clinical research including clinical trials for FDA regulated products through adequate inclusion of women and sex based analysis. OWH accomplishes these goals through partnerships and collaborations with scientists within and outside the FDA.
http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/default.htm
http://www.fda.gov/ForConsumers/byAudience/ForWomen/default.htm
 
I. Learning Objectives: Upon completion of this rotation the student will be able to:
A. Explain the development of a new drug from laboratory to commercial distribution of the product and the FDA’s role in that process.
B. Understand the importance of the study of sex differences in clinical research including clinical trials for FDA regulated products.
 
Student Requirements: The program will focus on familiarizing the student with the medical product development process (drugs, biologics, devices) and the importance of study of sex differences in the safety and efficacy of these products. To meet these objectives the student will be expected to:
 
A Conduct a research project assigned by the preceptor and to give a presentation
B. Attend the lecture series given by the FDA Pharmacy Student Experiential Program.
C. Fulfill required hours.