CDER Announces Emerging Drug Safety Technology Meeting Program

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On June 10, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced that it is publishing a notice in the Federal Register on June 11, 2024 (1) introducing the Emerging Drug Safety Technology Meeting (EDSTM) program. The meetings, which will be administered through CDER’s Emerging Drug Safety Technology Program (EDSTP), will provide those involved in pharmacovigilance activities (e.g., manufacturers, academia, contract research organizations, vendors, software developers) the ability to interact with CDER staff regarding the use of artificial intelligence (AI) in the advancement of pharmacovigilance.

The EDSTM program will facilitate learning and discussion regarding the application of emerging pharmacovigilance technologies and the verification and validation of these models. The EDSTP is a central point of contact for these discussions between industry and FDA that will enable knowledge management and transfer within the agency. EDSTP will also work to understand the scope of the use of AI and other technologies in pharmacovigilance and look for regulatory policies.

“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,” the agency stated in a press release.

“FDA plans to leverage these learnings to help inform potential regulatory and policy approaches, within the use of emerging technology in PV. The EDSTM program is not an avenue to seek regulatory advice on compliance with pharmacovigilance regulations. Rather, we expect that the information gained during this program will help CDER consider providing regulatory advice on specific technologies to facilitate their adoption when appropriate,” the agency states in the unpublished document (2).

Applicants may request EDSTMs on a rolling basis if they have at least one approved application with CDER, such as a new drug application, abbreviated new drug application, or biologics license application. Other individuals supporting industry pharmacovigilance activities may also request an EDSTM. These EDSTMS will be reviewed quarterly, and CDER will select up to nine participants that meet submission eligibility criteria.

“FDA has a longstanding commitment to ensure medicines marketed in the United States are safe through continued surveillance and research following approval. In the postmarket setting, regulated industry is obligated to review all adverse drug experience information received or otherwise obtained and submit timely reports to FDA,” the agency states in the document (2). “Both industry and regulatory authorities face challenges with timely and efficient collection, processing, and evaluation of single and aggregate patient safety data compounded by ever-increasing case volumes. Advances in emerging technology have the potential to address some of these challenges by creating more efficiencies within a PV system. For example, early adopters of AI are leveraging these emerging technologies to automate fundamental tasks (e.g., adverse event intake, data entry, and processing) with the intention to drive down associated administrative burden and costs. These technologies can also make safety surveillance more efficient and effective by capturing, aggregating, and analyzing larger and more diverse data sets.”

References

1. FDA. Hearings, Meetings, Proceedings, etc.: Emerging Drug Safety Technology Meetings, Program Announcement. Federal Register. June 10, 2024. https://www.federalregister.gov/public-inspection/2024-12770/hearings-meetings-proceedings-etc-emerging-drug-safety-technology-meetings-program-announcement
2. FDA. Emerging Drug Safety Technology Meetings; Program Announcement. [Docket No. FDA-2024-N-2332]. June 10, 2024. https://public-inspection.federalregister.gov/2024-12770.pdf