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: 
  • Disseminate scientific knowledge
  • Catalyze action among relevant stakeholders
  • Inform regulatory decision making

More information is available online via the FDA website.