When the head of the U.S. Food and Drug Administration sat down with two colleagues to talk about artificial intelligence a few weeks ago, he could hardly contain his excitement. Makary announced the launch of "Elsa." a generative AI tool the FDA says is already helping review the protocols of clinical trials, accelerate scientific reviews and identify targets for facility inspection. Susan Lee, a Washington, D.C.-based partner in the life sciences group at Goodwin, told Law360 Healthcare Authority it remains to be seen whether the agency's AI tool "is ready for prime time." The FDA announcement "puts us in pretty novel territory," she said. Susan Lee said attorneys and their clients should keep in mind that Al may be used to evaluate their submissions and "be ready to ask questions and to challenge decisions if it's appropriate." Lee is also mulling "emerging legal questions" about the possibility of leaked confidential data, whether Al might fail to treat similar applicants equally, and how it fits legally.