M-CERSI is an FDA-sponsored center at the Baltimore and College Park campuses of the University of Maryland, under the coordination of FDA Office of Regulatory Science and Innovation (ORSI). The mission of the Center is to foster the development of regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Many faculty think about aspects of regulatory science all the time, although many not fully realize it!
M-CERSI co-PIs Drs. James Polli (left) and William Bentley
This 9-minute video (accompanying presentation slides are available for download) aims to familiarize faculty with FDA outcomes of interest for regulatory science research projects.
As the FDA is a federal agency with significant public health responsibilities – particularly around the approval and labeling of medical products – it is helpful to be aware of FDA perspective of current research and research needs, as well as general research outcomes. FDA regulates medical devices, drugs, biological products, combination products, veterinary medicines, food, cosmetics, dietary supplements, and tobacco products.
Some examples of FDA employing tools, standards, and approaches are Biologics License Application (BLA) assessment, post-market surveillance, and devising product labels, industry guidance, and consumer updates.
Areas of regulatory science research can be thought in terms of efforts to:
Modernize development and evaluation of FDA-regulated products
Strengthen post-market surveillance and labeling of FDA-regulated products
Invigorate public health preparedness and response of the FDA, patients and consumers
Outcomes of interest for regulatory science research projects include: