Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

June 12, 2018 – Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for patients with a specific molecular sub-type. These more targeted treatments often address unmet medical needs. They can represent significant improvements over the prior standard of care. This medical progress is the result of scientific advancement. But it’s also a … (leggi tutto)