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CDER Emerging Drug Safety Technology Program (EDSTP)

Introducing the Emerging Drug Safety Technology Program (EDSTP)

Abstract network and data background.

The EDSTP is specifically focused on the use of artificial intelligence (AI) and other emerging technologies in pharmacovigilance (PV) and is part of the Center for Drug Evaluation and Research’s (CDER) multifaceted approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used across the drug product lifecycle.  

Emerging Technology's Potential in PV and Safety Surveillance

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 (per 21 CFR 314.80, 314.98, and 600.80) is obligated to review all adverse drug experience information received or otherwise obtained and submit reports to FDA. 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. 

Goals of the EDSTP

CDER recognizes industry’s interest in dialogue around AI capabilities that advance PV. Industry may have concerns that using such technologies could create uncertainties regarding satisfying regulatory obligations for PV. This is especially true while CDER familiarizes itself with new technologies (e.g., assessing their performance characteristics and efforts to validate and verify models) to determine how they may be evaluated within our regulatory framework. 

In this context, CDER established the EDSTP with three goals: 

  • Serve as the central point of contact for discussion between industry and CDER on the use of AI and other emerging technologies in PV 
  • Enable knowledge management and knowledge transfer within FDA specific to the context of AI or other emerging technologies used in PV
  • Understand the context of use of AI and other emerging technologies in PV to inform potential regulatory and policy approaches within PV

To help further these goals, CDER created the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered by the EDSTP. FDA expects that increased communication with the broader pharmaceutical industry during EDSTMs will accelerate FDA’s understanding of how AI enabled tools and other emerging technologies are being used for PV, their performance characteristics, their associated risks and benefits, efforts to validate and verify relevant models, and barriers to implementation. 

Questions and Answers

Contact Us

For more information regarding CDER’s Emerging Drug Safety Technology Program (EDSTP), email AIMLforDrugDevelopment@fda.hhs.gov and include the subject line “EDSTP – General Inquiry”

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