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KHN filed multiple Freedom of Information Act requests over months, and the FDA responded Wednesday saying the data about device malfunctions is now publicly available online.
The Food and Drug Administration released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices. Heres what weve learned so far.
In March, a chemical cousin of the anesthetic and club drug ketamine was approved for the treatment of patients with intractable depression. But critics say studies presented to the FDA provided at best modest evidence it worked and did not include information about the safety of the drug, Spravato, for long-term use.
Newsletter editor Brianna Labuskes wades through hundreds of health care policy stories each week, so you don't have to.
The FDA reveals that 56,000 malfunctions associated with surgical staplers werent reported through its traditional public reporting system.
The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.
As part of his plan to tamp down drug pricing, President Donald Trump wants pharmaceutical companies to provide cost information in drug ads just like side effects.
In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public database.
Critics are concerned about the explosion in controversial stem cell procedures offered by clinics and, increasingly, respected hospitals.
With Scott Gottlieb making his exit from the Food and Drug Administrations top spot, city and country health officials call for backup in the fight to curb teen use of e-cigarettes.
In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.
For almost two decades, device makers have sent reports of incidents to databases hidden from public view.
Only by the bizarre logic of the U.S. pharmaceutical industry does this drug count as any kind of generic.
In an interview, FDA Commissioner Scott Gottlieb reacts to a KHN/Fortune investigation of the drawbacks and risks of electronic health records.
Joanne Kenen of Politico, Anna Edney of Bloomberg News and Alice Miranda Ollstein of Politico join KHNs Julie Rovner to discuss the efforts to curb surprise medical bills to patients who inadvertently get out-of-network care; a look at where the 2020 presidential candidates stand on health; and the Trump administrations efforts to end HIV in the U.S. Also, Rovner interviews Food and Drug Administration Commissioner Scott Gottlieb, who is leaving his job in early April.
Newsletter editor Brianna Labuskes wades through hundreds of health articles from the week so you dont have to.
Stephanie Armour of The Wall Street Journal, Alice Ollstein of Politico and Rebecca Adams of CQ Roll Call join KHNs Julie Rovner to discuss the suggested cuts to health programs in President Donald Trumps budget proposal, the latest on lawsuits challenging work requirements for Medicaid enrollees and the FDAs crackdown on e-cigarettes. Plus, for extra credit, the panelists recommend their favorite health policy stories of the week.
The FDA said it might reclassify the widely used devices featured in a recent Kaiser Health News investigation.
Newsletter editor Brianna Labuskes wades through hundreds of health articles from the week so you dont have to.
The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, leaving doctors and medical sleuths in the dark.
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