FDA Explores AI for Drug Approvals, Faces Oversight Questions

FDA’s plan to roll out AI agencywide raises questions

(Axios) – The Food and Drug Administration is rolling out an aggressive plan to make generative AI a linchpin in its decision-making, part of a bid to get faster and leaner in evaluating drugs, foods, medical devices and diagnostic tests. Why it matters: The plan raises urgent questions about what’s being done to secure the vast amount of proprietary company data that’s part of the process and whether sufficient guardrails are in place. (Read Mo…

The FDA is turning to generative AI to boost efficiency

The Food and Drug Administration (FDA)  plans to launch generative AI across all of its centers by June 30. The announcement follows the appointment of the agency’s first chief AI officer, Jeremy Walsh, and the completion of an AI-assisted scientific review pilot. The generative AI rollout will allow FDA staff to spend less time on… The post The FDA is turning to generative AI to boost efficiency appeared first on Medical Design and Outsourcing.

FDA Explores AI for Drug Approvals, Faces Oversight Questions

The FDA has started exploring how AI can be used to accelerate drug approvals in collaboration with OpenAI amid oversight concerns

OpenAI and FDA explore AI for speeding up drug evaluations

OpenAI has reportedly met with officials from the U.S. Food and Drug Administration (FDA) to discuss the use of artificial intelligence (AI) in speeding up drug evaluations, according to a Wired report published on Wednesday. The discussions reportedly focused on a project named cderGPT, which appears to be an AI tool designed for the Center for Drug Evaluation and Research (CDER). CDER is responsible for regulating prescription and over-the-cou…