The FDA’s recent Evaluation of Labeling Submissions with AI (ELSA) pilot program has generated both curiosity and skepticism in the regulatory community. Early responses from reviewers using ELSA have been mixed, with some finding it helpful for catching inconsistencies or typos, while others found it redundant or disconnected from their workflows. While the effort is laudable, the ELSA pilot highlights deeper limitations in how general-purpose AI tools perform in complex, regulated environments

Instead of focusing on shrinking teams, medical writing leaders should use AI to expand their department’s scope and strategic value.

When implemented thoughtfully, AI can enhance job satisfaction, improve digital employee experience (DEx), and foster a great workplace culture.