Statement From FDA Commissioner on Agency Efforts to Advance the Patient Voice in Medical Product Development and Regulatory Decision-Making

June 22, 2018 – U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement: 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 subtype. These more targeted treatments often address unmet medical needs. They can represent significant improvements … (leggi tutto)