FDA Launches the Emerging Drug Safety Technology Program (EDSTP)

The U.S. Food and Drug Administration issued a Federal Register Notice announcing the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered through the Center for Drug Evaluation and Research’s (CDER) newly established Emerging Drug Safety Technology Program (EDSTP).  .

CDER recognizes industry’s interest in dialogue around artificial intelligence (AI) capabilities that advance pharmacovigilance (PV). Therefore, EDSTMs will provide applicants with an approved application and/or other relevant parties supporting industry’s PV activities (e.g., academia, contract research organizations, PV vendors, software developers), with an opportunity to meet with CDER staff to discuss their research, development, and use of AI and other emerging technologies in PV.

The goals of EDSTM 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 verify and validate relevant models. Specifically, the EDSTP is designed to:

• serve as the central point of contact for discussion between industry and FDA on the use of AI and other emerging technologies in PV;
• enable knowledge management and knowledge transfer within FDA specific to AI and other emerging technology use in PV; and
• understand the context of using AI and other emerging technologies in PV to inform potential regulatory and policy approaches within PV.

FDA expects increased communication with industry and/or other relevant parties during EDSTMs will accelerate our understanding of how AI-enabled tools are being used for PV, their associated risks and benefits, and barriers to implementation.

We encourage interested parties to visit the EDSTP webpage for more information about the program, including information on eligibility and selection criteria and how to request a meeting.