FDA launches EDSTP to foster use of emerging technologies in pharmacovigilance

The US 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).

The CDER recognizes industry’s interest in dialogue around artificial intelligence (AI) capabilities that advance pharmacovigilance (PV). Therefore, the FDA noted, EDSTMs will provide applicants with an approved application and/or other relevant parties supporting industry’s PV activities (eg, 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.

Goals of the program