FDA rushed out agency-wide AI tool—it’s not going well
a year ago
- #Regulation
- #FDA
- #Artificial Intelligence
- The FDA under the Trump administration is adopting AI tools, including a large language model (LLM) called Elsa, despite concerns from staff about its readiness.
- Elsa is intended to assist FDA employees in tasks like clinical protocol reviews, scientific evaluations, and identifying inspection targets.
- The AI tool promises to summarize adverse events, perform label comparisons, and generate code for nonclinical applications.
- FDA Chief AI Officer Jeremy Walsh and Commissioner Marty Makary praised the rollout, highlighting its speed and cost-effectiveness.
- However, initial tests by FDA staff revealed that Elsa provided summaries that were either completely or partially incorrect.