Patricia Spitzig

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  • Bryan Benesch, Ron Parr, Timothy Stockdale, D Bruce Burlington, Director, John Stigi +14 others
ii FOREWORD The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) develops and implements national programs and regulations to protect the public health in the fields of medical devices and radiological health. These programs are intended to insure the safety, effectiveness, and proper labeling of medical and(More)
Federal regulations are the minimum requirements for conducting clinical studies. Some innovation would improve the situation of many involved in these studies, including: study subjects, those who monitor studies, and clinical investigators as well as Institutional Review Boards. Respecting patient and whistle-blower input; appreciating research staff(More)
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