Jesse Goodman
Former FDA official and agency veteran who offers expert analysis on regulatory practice, refuse-to-file decisions, and the FDA review process in the episode.
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Feb 12, 2026 • 51min
388: The FDA's refusal to review Moderna's mRNA flu vaccine
Jesse Goodman, former FDA official with deep regulatory experience, offers perspective on refuse-to-file norms. Lizzy Lawrence, STAT reporter, brings inside reporting on FDA vaccine office dynamics. Stephen Hoge, Moderna president, explains the company’s mRNA flu strategy and regulatory interactions. They discuss the FDA blocking review, trial design disagreements, comparators, and how agency decisions affect innovation and global strategy.
Jan 26, 2026 • 21min
1001 - Vaccines 101: How FDA Regulates Vaccines
Dr. Jesse Goodman, former FDA chief scientist and current Georgetown professor who studies medical product safety. He walks through how FDA reviews vaccine safety, manufacturing, and monitoring. He describes the multidisciplinary teams and vaccine ingredients. He raises concerns about leadership interference and the risks to the agency’s credibility and public trust.
