FDA Launches The Emerging Drug Safety Technology Program (EDSTP) To Foster Engagement On The Use Of Emerging Technologies In Pharmacovigilance | Open Call For Honorable Scientists
OK scientists - call FDA - they are claiming to want to foster 'engagement', so you BETTER TAKE EM UP ON THIS ONE!! Get in there and keep us safe from the EMERGING TECHNOLOGIES!
FDA sent IOJ this message today and we thought some of you may like to know.
We hope some scientists and Doctors will get involved in the program promising ‘engagement’ on the use of emerging technologies in pharmacovigilance. Why? To be oversight of the emerging technology. For the FDA to open up engagement is great, but it’s useless if dissenting experts don’t apply and penetrate zee program and engage. That’s our take. - IOJ
link to program doc on Federal Register today: https://public-inspection.federalregister.gov/2024-12770.pdf
FDA launches the Emerging Drug Safety Technology Program (EDSTP) to foster engagement on the use of emerging technologies in pharmacovigilance
Today, the U.S. 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).
CDER recognizes industry’s interest in dialogue around artificial intelligence (AI) capabilities that advance pharmacovigilance (PV). Therefore, EDSTMs will provide applicants with an approved application and/or other relevant parties supporting industry’s PV activities (e.g., 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.
The goals of EDSTM program in its initial phase are to facilitate mutual learning and discussion of the pharmaceutical industry’s application of these technologies to PV, including efforts to verify and validate relevant models. Specifically, the EDSTP is designed to:
serve as the central point of contact for discussion between industry and FDA on the use of AI and other emerging technologies in PV;
enable knowledge management and knowledge transfer within FDA specific to AI and other emerging technology use in PV; and
understand the context of using AI and other emerging technologies in PV to inform potential regulatory and policy approaches within PV.
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 Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
SUMMARY FROM FEDERAL REGISTER: The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or we) is announcing a meeting program, the Emerging Drug Safety Technology Meeting (EDSTM) program. These meetings will be administered by staff in the newly established CDER Emerging Drug Safety Technology Program (EDSTP). EDSTMs provide applicants with an approved application and/or other relevant parties supporting industry’s pharmacovigilance (PV) activities (e.g., academia, contract research organizations (CROs), pharmacovigilance vendors, software developers) who meet the eligibility and selection criteria for participation with an opportunity to meet with CDER staff to discuss their research, development, and use of Artificial Intelligence (AI) and other emerging technologies in PV.
The goals of the meeting program in its initial phase are to facilitate mutual learning and discussion of the pharmaceutical industry’s application of these technologies to PV, including efforts to validate and verify relevant models.
While the EDSTP is specifically focused on the use of AI in PV for postmarket activities, it is part of CDER’s multifaceted approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used across the drug product life cycle.
DATES: Applicants and other relevant parties may submit meeting requests under the program beginning Monday June 10, 2024
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Well, okay, but I'm totally in favor of ABOLISHING the FDA! Completely. They do not work for the good of Americans.
Screw this... I'm going back to herbs, tinctures, sound, light, pure food, exercise, sleep, and laughter!!...