Emerging Drug Safety Technology Meetings; Program Announcement

The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or we) is announcing a meeting program, the Emerging Drug Safety Technology Meeting (EDSTM) program. These meetings will be administered by staff in the newly established CDER Emerging Drug Safety Technology Program (EDSTP). EDSTMs provide applicants with an approved application and/or other relevant parties supporting industry's pharmacovigilance (PV) activities (e.g., academia, contract research organizations (CROs), pharmacovigilance vendors, software developers) who meet the eligibility and selection criteria for participation with an opportunity to meet with CDER staff to discuss their research, development, and use of Artificial Intelligence (AI) and other emerging technologies in PV. The goals of the meeting program in its initial phase are to facilitate mutual learning and discussion of the pharmaceutical industry's application of these technologies to PV, including efforts to validate and verify relevant models. While the EDSTP is specifically focused on the use of AI in PV for postmarket activities, it is part of CDER's multifaceted approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used across the drug product life cycle.

Abstract as published in the Federal Register.