Today’s guest, Dr. Sandra Kweder, spent 35 years at the FDA, from a young medical officer during the AIDS epidemic to over a decade as deputy director of the Office of New Drugs and FDA’s liaison to the European Medicines Agency.
In this episode, we use her career to explore how and why the FDA changes as an institution. She takes us back to the AIDS crisis, when activists called her at home, and the agency learned that patients with everything to lose think about risk differently. We dig into how user fees transformed a drug review process where applications once sat untouched for years, and how FDA and Europe reach the same decisions about 97% of the time despite completely different systems. Finally, she offers a candid look at today’s FDA and why, even in an age of AI, good regulation still comes down to judgment.