BioCentury
ARTICLE | Regulation

Organizing for cures

Back to School 2025: Medical products regulation should be reorganized to reflect how medicine is practiced and how patients experience disease

August 13, 2025 11:53 PM UTC

FDA’s oversight of medical products is overdue for major reorganization, one that aligns the agency’s structure with the goals that matter most to patients and society. It should be focused on diseases, not technologies, with teams dedicated to creating conditions that can pave the way for products that produce exponential improvements in health.

The organization of FDA, or the dedicated medical products regulator Back to School is calling for, should reflect the ways medicine is practiced and, importantly, the ways patients experience disease. ...