In the 19th and 20th centuries, medicine focused on killing germs. Today, most healthcare involves tuning our systems. Tomorrow’s regimens will be guided and adjusted using relevant biomarkers specific to individual patients. Yet the FDA is still optimized for the mass-market drugs like antibiotics and vaccines. It now has evolved into a bureaucracy more concerned with avoiding risks than speeding the benefits of innovation to patients. The result is a minefield that lies between patients and medical breakthroughs. How significant is this minefield? What can and should be done about it? What are the major implications? We’ll show you.