Drugs and the FDA: Safety, Efficacy, and the Public's Trust (The MIT Press)
Drugs and the FDA
by Mikkael A. Sekeres
English | 2022 | ISBN: 0262047314 | 303 pages | True EPUB | 8.58 MB
by Mikkael A. Sekeres
English | 2022 | ISBN: 0262047314 | 303 pages | True EPUB | 8.58 MB
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin.
Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer’s drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug’s safety and efficacy? In Drugs and the FDA, Mikkael Sekeres—a leading oncologist and former chair of the FDA’s cancer drug advisory committee—tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices.
Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a…