The world needs to know the facts as to how the FDA “protects” the public health by assuring the safety, effectiveness, and security of human drugs and biological products for human use. Recent uproar has surfaced o...The world needs to know the facts as to how the FDA “protects” the public health by assuring the safety, effectiveness, and security of human drugs and biological products for human use. Recent uproar has surfaced over the FDA’s approval process on the unproven Duchenne Muscular Dystrophy (DMD) drug, Exondys 51 (Sarepta Therapeutics, Cambridge, MA, USA), but what many people do not know are the unlawful events that occurred nearly two decades ago on a proven and promising treatment for DMD.展开更多
文摘The world needs to know the facts as to how the FDA “protects” the public health by assuring the safety, effectiveness, and security of human drugs and biological products for human use. Recent uproar has surfaced over the FDA’s approval process on the unproven Duchenne Muscular Dystrophy (DMD) drug, Exondys 51 (Sarepta Therapeutics, Cambridge, MA, USA), but what many people do not know are the unlawful events that occurred nearly two decades ago on a proven and promising treatment for DMD.