Drugs

Emerging Drug Safety Technology Meeting Program

FDA is announcing an Emerging Drug Safety Technology Meeting (EDSTM) program to assist industry in implementing artificial intelligence (AI) capabilities in their pharmacovigilance (PV) activities. The program will provide stakeholders an opportunity to meet with CDER staff to discuss their research, development, and use of AI and other emerging technologies in PV. Its initial goals 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,” an agency notice says.

FDA says it designed EDSTP to:

serve as the central point of contact for discussing 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.

The agency is directing interested parties to visit the EDSTP Web page for more information about the program, including information on eligibility and selection criteria and how to request a meeting.

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