Binding: Paperback
Description: How the FD a 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 FD a the ultimate US authority on a drug's safety and efficacy? In Drugs and the FD a Mikkael Sekeres a leading oncologist and former chair of the FD a's cancer drug advisory committee tells the story of how the FD a 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 FD a existed drug makers could hawk any potion claim treatment of any ailment and make any promise on a label. But then throughout the twentieth century the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines an early antibiotic contained antifreeze a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin in which he participated as a panel member. The Avastin hearings he says put to the test a century of the FD a's evolution demonstrating how its system of checks and balances works or doesn t work.
Title: Drugs And The Fda Safety Efficacy And The Public's Trust
Author(s): Sekeres Mikkael A.
Publisher: Mit Press Ltd
Barcode: 9780262548397
Pages: 320 Pages, 20 Black And White Illus.
Publication Date: 2/6/2024
Category: Medical & Healthcare Law