FDA announces overhaul of medical device approval system
November 28, 2018
By Neozene

The FDA plans to overhaul the decades-old medical device approval system that has been criticized by experts for risky implants and failure to catch problems, it announced Monday. The decision comes one day after an investigation on global medical device safety was published by the International Consortium of Investigative Journalists (ICIJ) — with over 250 journalists from more than 50 organizations helping with the investigation. The investigation found more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices over a 10-year period in the

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US FDA Clarifies Human Subject Requirements for Clinical Investigations
October 23, 2018
By Neozene

New guidance from the US Food and Drug Administration explains how its clinical investigation requirements pertaining to human subject protection policies correspond to US federal policy on human subject protections enforced by the Department of Health and Human Services (HHS). The guidance is intended to explain how sponsors whose medical device and pharmaceutical clinical investigations must meet both FDA clinical investigation regulations for human subject safety and informed consent as well as HHS’s “Common Rule” for human subject protections should address compliance issues. In general, the guidance recommends that in

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FDA fights EpiPen shortage by extending expiration date for some devices
August 21, 2018
By Neozene

The FDA took steps Tuesday to mitigate the shortage of EpiPens by allowing some expired devices for treating life-threatening allergic reactions to remain on the market. The FDA said that after reviewing data, it had decided it can extend the expiration date by four months for specific lots of EpiPens that are expired or close to expiring. “Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can

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