FDA
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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...
Clinical Care
FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records
Secretary Scott Gottlieb said Congress would need to enact legislation to define when an electronic health record would require government...
Strategy
Gottlieb Confident in FDA's Direction as His Departure Nears
The decision to leave the agency did not come easily, but the commissioner said he feels good about where things...
Clinical Care
Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices
The FDA has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which...
Strategy
Cities And Counties Unlikely To Heed FDA Warning On Importing Foreign Drugs
Prices of drugs from overseas pharmacies can be as much as 70% lower than what people pay in the U.S....
Strategy
Despite Early Skepticism, FDA's Scott Gottlieb Won Wide Approval
The doctor and venture capitalist, who announced his resignation Tuesday as FDA commissioner, served nearly two years in the Trump...
Clinical Care
Patients Question How FDA Approves Medical Devices
More ailments are being treated with medical devices, including implants. And most of these, unlike pharmaceuticals, don't go through human...
'Not Good Enough': FDA Let Inappropriate Fentanyl Scripts Go On
A new study finds that as many as half of the patients taking highly potent transmucosal immediate-release fentanyl should not...