The FDA’s drug center is creating a new way for sponsors to talk with the agency about how they’re using artificial intelligence and other technologies to conduct pharmacovigilance, the regulator announced Monday.
The new meeting type, called the Emerging Drug Safety Technology Meeting (EDSTM) program, is meant to give sponsors the chance to ask the FDA questions as they they implement AI and other methods to monitor drug safety. The FDA will generally decide whether to grant a meeting based on factors like its own knowledge in a particular area and how the uses, or proposed uses, will satisfy regulations around pharmacovigilance, the FDA said in its announcement.
“The EDSTM program is not an avenue to seek regulatory advice on compliance with pharmacovigilance regulations,” the FDA wrote. “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 FDA clarified that the meeting type will be available to sponsors with at least one approved application overseen by CDER, including new drug applications, abbreviated new drug applications and biologics license applications.
Other parties, including academics and pharmacovigilance vendors, can also submit requests for meetings, either in combination with the applicant or separately.
The first deadline to request a meeting is Oct. 1, and the FDA will respond to requests within 45 days.