Description

Book Synopsis
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 label. But

Drugs and the FDA

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    A Paperback by Mikkael A. Sekeres

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      Publisher: MIT Press
      Publication Date: 2/6/2024 12:00:00 AM
      ISBN13: 9780262548397, 978-0262548397
      ISBN10: 0262548399
      Also in:
      Medical and healthcare law

      Description

      Book Synopsis
      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 label. But

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