FDA Commissioner Margaret Hamburg devoted a large part of her luncheon remarks at the annual AdvaMed MedTech Conference in Chicago to boosting the American device industry's global competitiveness.
The FDA has awarded 15 grants totaling more than $19 million to spur the development of medical devices and drugs to help treat rare diseases.
The FDA announced that it has finalized its guidance on managing cybersecurity risks as it aims to protect patient privacy and prevent devices from malfunctioning due to computer viruses.
Breast cancer detection may soon leave 2-D mammography in the dust, embracing instead a more comprehensive diagnostic tool: 3-D technology.
A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.
The FDA's powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress' procedural requirements when reclassifying devices, including notice and comment procedures.
The problem of contaminated cold remedies has once again surfaced in the U.S. More than seven years after diethylene glycol put authorities on high alert, a toddler in New York has suffered from lead poisoning after taking a Chinese cold remedy.
It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis and Roche. Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.
The FDA has set aside $16 million for tracking which drugs are used, in what combinations and for how long, Regulatory Focus reports.
The FDA's Mini-Sentinel has long since outgrown its "mini" moniker and is now ready to graduate from being a pilot project to being an integral part of the agency's drug-safety infrastructure. Many people welcome the program's progress, but doubts and dissenting voices remain.