Discourse and Research from TechLaw
Focus Areas: Regulatory Science
A partnership between University of Arizona Health Sciences and the James E. Rogers College of Law, the Regulatory Science Program exists to identify and pioneer smart forms of regulation and to train the next generation of advocates, regulators, scientists and clinicians about best practices in this area.
The Food and Drug Administration (FDA) defines “regulatory science” as “the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products.”
The FDA and the National Institutes of Health have identified regulatory barriers as one of five key difficulties with bringing new drugs, devices and diagnostics to market. According to the National Institutes of Health, the need is to “modernize our evaluation and approval processes to ensure that innovative products reach the patients who need them, when they need them.”