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FDA News & Recalls

  • Freeze-dried plasma
    Defense Bill Could Bypass FDA Drug, Device Approvals
    A bill before Congress would allow the Defense Department instead of the FDA to approve certain drugs and medical devices for deployed troops. Military…
    Terry Turner
    Terry Turner November 8, 2017
  • Collage of individual diverse people
    Study: Medical Device Safety Not Evaluated by Age, Sex or Race
    Study: Medical Device Safety Not Evaluated by Age, Sex or Race Clinical trials used to establish the safety of medical devices usually fail…
    Elaine Silvestrini
    Elaine Silvestrini October 27, 2017
  • Senior Couple With Pill Bottles And Laptop
    FDA Untangles Dangerous Drug Searches
    In the past 10 years, the U.S. Food and Drug Administration has received more than 5.4 million reports of serious adverse events associated…
    Terry Turner
    Terry Turner October 2, 2017
  • signing a document with medical device equipment in the background
    Report: Medical Device Modifications Approved with Poor Data
    When manufacturers make significant changes to high-risk medical devices, the Food and Drug Administration approves the modified devices based on poor-quality data or…
    Elaine Silvestrini
    Elaine Silvestrini September 14, 2017
  • Shaking Hands over Prescription Drugs
    Studies: Major Flaws Found in Some Drug Approvals
    Evidence used to support the government’s approval of some prescription drugs suffers from “major flaws,” according to the findings of two new studies. Specifically,…
    Elaine Silvestrini
    Elaine Silvestrini September 6, 2017
  • Warning sign that says Product Recall
    FujiFilm Issues Urgent Duodenoscope Recall
    Months after the company removed four models of its duodenoscopes from the market, device maker Fujifilm Medical Systems has issued an “urgent” recall of…
    Elaine Silvestrini
    Elaine Silvestrini July 25, 2017
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