The OpenAI company is in talks with the US Food and Drug Administration (FDA) about using artificial intelligence to speed up drug review. About this informs Wired.
The project in question is called cderGPT, an AI-based tool that is believed to be being created for the Center for Drug Evaluation (CDE), a division of the FDA that regulates both prescription and over-the-counter drugs in the US.
Representatives of DOGE, an organization associated with Elon Musk, also joined the discussions. New drug development typically takes more than a decade, and applying artificial intelligence to support the final stages of drug review can help shorten at least part of the traditionally time-consuming drug development process. Most drugs fail before they even get to the FDA review stage.
The FDA’s application review process typically takes about a year, but the agency already has a number of mechanisms in place to speed up the process for promising drugs. Among them is expedited review status, which applies to drugs aimed at treating serious diseases and designed to meet unmet medical needs. Another tool is breakthrough therapy status, introduced in 2012, which allows the FDA to prioritize candidates that can provide significantly better treatment outcomes compared to existing methods.
Artificial intelligence has long been considered a potentially effective tool in pharmaceutical research, but questions remain about the accuracy of such models and control over possible errors.
