FDA
publication date
Finance
Judge Vacates HHS Rule That Would Require Drug Price Disclosure in TV Ads
The ruling is likely to be challenged at the United States Court of Appeals for the District of Columbia Circuit.
Five Things We Found In The FDA's Hidden Device Database
The FDA has released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices.
FDA Overlooked Red Flags In Drugmaker's Testing of New Depression Medicine
Spravato maker Janssen provided the FDA modest evidence that it worked and only in limited trials. It presented no information...
With Public Meeting, FDA Signals Interest in New Opioid Limits
Agency seeks input on possible approaches to discourage high-dose prescribing.
Clinical Care
FDA Launches Pilot Program for Unapproved Cancer Therapies
Expanded Access provides patients with life-threatening diseases access to experimental medical products, including drugs, and biologic or medical devices.
More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database
The agency convened a meeting of experts this week to help it determine whether surgical staplers should be moved out...
PharMEDium Hit with Permanent Injunction
The maker of ready-to-use IV bags and preloaded syringes has been repeatedly cited for safety concerns at its four manufacturing...
FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices
FDA officials announced the decision to terminate the program in a statement on increasing transparency about the safety of breast...
Clinical Care
FDA: No More Mesh for Prolapse Repair
Manufacturers Boston Scientific and Coloplast have 10 days to provide exit plan for products.
Strategy
Gottlieb's Last Day: FDA Commissioner Returns to Conservative Think Tank
The part-time role will reportedly occupy only about six hours of Gottlieb's time each month, leaving quite a bit of...
Innovation
FDA Moves to Curb Insulin Price Hikes as Pressure on Manufacturers Mounts
Insulin manufacturers have long been criticized for raising their list prices year after year. Now the FDA aims to make...
Clinical Care
Device-Safety Experts To FDA: Make Data Public
Researchers say the agency needs to open the data on scores of medical devices, which have included mechanical ventilators and...