In 2007, an agency panel found that the FDA’s "scientific workforce does not have sufficient capacity and capability" and the agency is "not positioned to meet current or emerging regulatory responsibilities." The Pew Charitable Trusts wanted to know if that’s still the case, and asked the Partnership for Public Service to find out. "FDA has made progress," says the Partnership’s report, but the agency "continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed."More info
Director, Innovate FDA, , The Pew Charitable Trusts
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Kathleen Stratton directs Innovate FDA, an initiative that promotes the development of safe and effective medical treatments by fostering and supporting improvements in the FDA’s scientific staff, tools, and regulatory processes. Prior to her work at Pew, Stratton served as a scholar at the Institute of Medicine (IOM) of the National Academies of Science for 21 years where she had management and research responsibilities for projects in the areas of drug and vaccine safety, tobacco control, and public health preparedness. In October 2002, she was awarded the IOM’s Cecil Research Award for her sustained contributions to vaccine safety.
Stratton received an undergraduate degree in natural sciences from Johns Hopkins University, Baltimore, Maryland, and earned her Ph.D. in pharmacology and toxicology from the University of Maryland at Baltimore. She completed a postdoctoral research fellowship in the Department of Neuroscience at Johns Hopkins University School of Medicine.
"Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs."More info