The FDA is exploring the use of AI, specifically through discussions with OpenAI, to expedite the drug approval process. This initiative, led by the FDA's first AI officer, aims to modernize regulatory reviews, although concerns about AI reliability and proper data training persist.
The FDA has launched Elsa, a generative AI tool aimed at enhancing operational efficiency across the agency. Designed to assist employees with tasks such as reading, writing, and summarizing, Elsa will streamline processes like clinical protocol reviews and safety profile assessments while ensuring data security. This initiative marks the beginning of the FDA's broader integration of AI technologies.