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February 27, 2012

New Online Course Content Explores FDA Regulatory Process

The U.S. Cochrane Center at the Johns Hopkins Bloomberg School of Public Health has launched a new module for its online course Understanding Evidence-based Healthcare: A Foundation for Action, which covers the Food and Drug Administration (FDA) regulatory process. The new “Spotlight Session” focuses on the history of drug regulation and the fundamentals of how drugs are approved in the U.S., providing real-life examples. The course module is available free of charge.

“This new module teaches many aspects of the regulatory process not easily obtained from other sources,” said Kay Dickersin, PhD, a professor in the Bloomberg School of Public Health’s Department of Epidemiology and director of the U.S. Cochrane Center. “With the knowledge participants gain from our course, they will positively influence responsible public health care policy and help the people they serve to make evidence-based health care choices.”

The module was co-developed and narrated by Musa Mayer, a breast cancer advocate and author who served for a decade as a patient representative on FDA advisory committees. “FDA’s role in drug development is often misunderstood,” said Mayer.  “We wanted advocates and others who care about new treatments for serious diseases to understand how the complex approval process reflects available evidence about a new drug’s efficacy and safety. By using both current and past examples, we hope to convey a real sense of the history and dynamics behind FDA regulation.”

The new module is the latest addition to the free 6-module online course, Understanding Evidence-based Healthcare: A Foundation for Action, which was first launched in 2007. In 2010, Dickersin and Mayer collaborated with Johns Hopkins faculty member Steve Goodman, MD, PhD, to create a version of the course for physician training. The courses illustrate key concepts in evidence-based health care through real-world examples. In all, the six modules—an introduction to evidence-based health care; the importance of research questions; research design, bias and levels of evidence; searching for health care information; understanding health care statistics; and critical appraisal of research articles—include lectures and case studies, divided into 10- to 15-minute segments.

“By providing both consumers and doctors with a freely available course,” Dickersin said, “the two groups will have access to information useful for interpreting research evidence and a stronger basis for effective partnership.”  This suite of free courses was undertaken as a project of Consumers United for Evidence-based Healthcare (CUE), a consumer advocate arm of the U.S. Cochrane Center, one of 13 centers worldwide participating in the Cochrane Collaboration. The Collaboration promotes resources that examine the benefits and risks of health care to help people make well informed decisions about their health.

Understanding Evidence-based Healthcare: A Foundation for Action and the suite of free courses are available by visiting The new FDA module is available at

The original consumer course was funded in part by a grant from the Agency for Health Care Research and Quality, and the physician version of the course by a grant from Blue Shield of California. The new Spotlight Session on the FDA was funded by a grant from the Agency for Healthcare Research and Quality.

Media contact: Tim Parsons, director of Public Affairs, at 410-955-7619 or