Category Archive: fda

FDA Overlooked Red Flags In Drugmaker’s Testing of New Depression Medicine

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.

Must-Reads Of The Week From Brianna Labuskes

Newsletter editor Brianna Labuskes wades through hundreds of health care policy stories each week, so you don’t have to.

More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.

Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device

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.

FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

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.

Elite Hospitals Plunge Into Unproven Stem Cell Treatments

Critics are concerned about the explosion in controversial stem cell procedures offered by clinics — and, increasingly, respected hospitals.

Health Officials’ Plug For Next FDA Chief: Go Big On E-Cig Regulation

With Scott Gottlieb making his exit from the Food and Drug Administration’s top spot, city and country health officials call for backup in the fight to curb teen use of e-cigarettes.

FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices

In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.

Device-Safety Experts To FDA: Make Data Public

For almost two decades, device makers have sent reports of incidents to databases hidden from public view.

FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records

In an interview, FDA Commissioner Scott Gottlieb reacts to a KHN/Fortune investigation of the drawbacks and risks of electronic health records.

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