Lexology October 16, 2025
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.
Not in Kansas Anymore: FDA Signals New Era of Drug Safety Warnings Being Imposed on Sponsors Without Notice
What is happening: President Donald Trump, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., and FDA Commissioner Dr. Marty Makary (along with the National Institutes of Health director) spent the afternoon of September 22, 2025 at a press conference making unsupported, unbalanced, and unprecedented claims about the existence of a causal connection between acetaminophen taken during pregnancy and autism. FDA followed up the same day with an announcement that it...
Today's Sponsors
Today's Sponsor