Welcome to the PSC 646 Regulatory Science Guide!
Here you will find sources, by no means exhaustive, on bringing new medical products to market, developing methods and standards for assessing new products, and reviewing the US regulatory system.
Please email me with any questions or suggestions to add to the course guide. I would be happy to hear from you.
From Dr. Zheng's Spring 2016 Course Syllabus:
Regulatory Science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of products, according to the definition by the US Food and Drug Administration (FDA). This course provides an overview of the regulatory process from new discoveries to commercialization, for drugs, biologics, medical devices and other products for healthcare. We will examine the history and current status of the US federal regulations, and review the current operations and policies of the FDA. Global regulatory strategies will also be disused by highlighting common scientific foundations, principles, rationales, and relationships of the laws, ethics, economics, clinical practice, and globalization issues.
