Showing results 1 - 5 of 5
November 2024, Paper: "Countries with small and/or less-resourced regulatory authorities that operate outside of a larger medical product regulatory system face a regulatory…
July 2024, Paper: "The Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD) program was created to increase patient access to safe and effective therapies…
March 2024, Paper: "Digital health technologies (DHTs) can enable more patient- centric therapeutic development by generating evidence that captures how patients feel and function…
December 2022, Paper: "Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s…
2022, Paper: "Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical…