The FDA’s Center for Drug Evaluation and Research (CDER) has recently announced plans to launch the Emerging Drug Safety Technology Meeting (EDSTM) program. This initiative, set to be administered through CDER’s Emerging Drug Safety Technology Program (EDSTP), aims to engage various stakeholders in the discussion of the use of artificial intelligence (AI) in pharmacovigilance.
The EDSTM program seeks to foster a collaborative environment where industry professionals, academia, software developers, and other relevant parties can interact with CDER staff to explore the application of novel pharmacovigilance technologies, particularly AI, and to address the verification and validation of these models. This program will also serve as a platform for knowledge exchange and help the FDA gain insights into the utilization of AI and other technologies in pharmacovigilance as well as explore potential regulatory policies.
According to a press release by the agency, the EDSTM program is expected to enhance communication between the FDA and industry stakeholders, leading to a deeper understanding of the uses, risks, benefits, and hurdles associated with AI-enabled tools in pharmacovigilance. The FDA encourages interested parties to visit the EDSTP webpage for further details about the program, including eligibility criteria and the process for requesting a meeting.
It is emphasized that the EDSTM program is not intended for seeking regulatory advice on compliance with pharmacovigilance regulations. Instead, the FDA aims to utilize the knowledge gained from this program to inform potential regulatory and policy approaches for the use of emerging technology in pharmacovigilance.
Eligible applicants may request EDSTMs on an ongoing basis, provided they have at least one approved application with CDER, such as a new drug application, abbreviated new drug application, or biologics license application. Additionally, individuals involved in supporting industry pharmacovigilance activities may also request an EDSTM. The submissions will be reviewed quarterly, with CDER selecting up to nine participants who meet the eligibility criteria.
The FDA has expressed its commitment to ensuring the safety of medications in the United States through continuous surveillance and research following approval. The agency acknowledges the challenges faced by both industry and regulatory authorities in collecting, processing, and evaluating patient safety data, particularly with the increasing volume of cases. It is believed that advancements in emerging technology, such as AI, have the potential to address some of these challenges by streamlining pharmacovigilance processes, driving down administrative burden and costs, and improving the efficiency and effectiveness of safety surveillance.
For original announcements and further information, interested parties can refer to the following sources:
1. FDA. Hearings, Meetings, Proceedings, etc.: Emerging Drug Safety Technology Meetings, Program Announcement. Federal Register. June 10, 2024.
2. FDA. Emerging Drug Safety Technology Meetings; Program Announcement. [Docket No. FDA-2024-N-2332]. June 10, 2024.