Hilary Schmidt's credentials suggest academic rigor. Schmidt has a PhD in psychology from the University of Pennsylvania and has spent years studying how medical students learn. But when she joined Aventis two-and-a-half years ago as head of medical education, her new employer introduced her on stage at a national meeting wearing a white karate uniform and black belt -- the trappings of years spent studying a very different discipline. They both had a big commitment to supporting medical education of the highest quality and ensuring compliance with all the relevant regulatory bodies, recalls Schmidt, who is now associate VP, medical education, for Sanofi-Aventis. Most of the top 10 pharma firms now have online grant systems, and many grantors are starting to require the same types of in...
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.'' This guidance document is intended to provide information on the implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance document describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this provision of the law. The Pilot Program will be effective June 5, 2012.
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