Overview

• The FDA has introduced Elsa, a generative AI tool to assist in safety data review, report summarization and inspection targeting in drug and device applications.
• Agency officials aim to shorten the last stages of approval to a few weeks by leveraging AI to process as many as 500,000 pages of application data, citing Operation Warp Speed.
• Early users report Elsa can produce “hallucinations,” misstate facts and cannot analyze larger datasets, meaning outputs must be manually verified.
• The FDA’s workforce has fallen by about 1,940 employees to roughly 8,000, and the agency faces proposed overall budget cuts alongside increased funding for its food safety division.
• The modernization drive also includes reassessing food additives like artificial dyes, and FDA officials have drawn criticism for closed-door meetings with drug industry executives.