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.
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t 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.
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.
Hospitals and nursing homes in California and Illinois hope that regional cooperation — and a special soap — will help them gain the upper hand against deadly antibiotic-resistant superbugs.
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.
Sen. Lamar Alexander (R-Tenn.), head of the influential HELP committee, wants to make it easier to share and store detailed medical histories.
In an interview, FDA Commissioner Scott Gottlieb reacts to a KHN/Fortune investigation of the drawbacks and risks of electronic health records.
The U.S. government claimed that ditching paper medical charts for electronic records would make health care better, safer and cheaper. Ten years and $36 billion later, the digital revolution has gone awry.
