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The Irony of the FDA’s Role as ‘Protector of the Public’

  • May 14, 2019

The U.S. Food and Drug Administration has announced it will end alternative summary reporting, a program that allowed medical device companies to keep reports of harm and malfunction from the public. The FDA announced the conclusion of the program a month after a Kaiser Health News investigation reported that the FDA has collected 1.1 million reports since 2016, none of which were publicly available. In particular, makers of breast implants have been able to report adverse events and keep the...
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