The Emerging Drug Safety Technology Program (EDSTP) is dedicated to the integration of artificial intelligence (AI) and emerging technologies within pharmacovigilance (PV) to advance drug safety and lifecycle management. This program fosters communication with the pharmaceutical industry to enhance the FDA’s understanding of AI-enabled tools and other technologies in PV, aiming to assess their performance, risks, benefits, validation, and implementation barriers.
The Center for Drug Evaluation and Research (CDER) of the FDA seeks to utilize these innovations to enhance the efficiency of drug safety surveillance and reporting processes. In the post-market phase, the regulated industry is mandated to review and report adverse drug experiences to the FDA. However, the increasing volume of cases presents significant challenges in the timely and efficient collection, processing, and evaluation of data. AI and other emerging technologies present viable solutions by automating tasks such as adverse event intake and data processing, thereby reducing administrative burdens and associated costs.
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