FDA cuts fiscal 2015 user fees
The FDA is cutting the fiscal 2015 user fees paid by medical device companies to have their products reviewed by 3% across the board.
The FDA is cutting the fiscal 2015 user fees paid by medical device companies to have their products reviewed by 3% across the board.
Google isn’t just searching the Internet. The company will soon search the insides of people’s bodies for new biomarkers by collecting their urine, blood, saliva and tears as part of its Baseline Study initiative.
The National Institutes of Health is launching three new programs in emerging areas with the lofty goal of transforming biomedical research in the next 5 to 10 years.
Complications of diabetes are more easily treated when they are found early. Researchers at National Taiwan University Hospital have developed a wearable optical device to detect diabetic autonomic neuropathy, a common diabetic complication, that could be better than existing detection methods.
In response to back-to-back incidents involving government laboratories, a top official at the U.S. Centers for Disease Control and Prevention has resigned, and the agency has assembled a safety board to address concerns that have arisen after workers were potentially exposed to anthrax and H5N1 flu.
In a new final guidance issued in July, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which the Agency later said can damage surrounding bones and contaminate the body by releasing ions into the bloodstream.
A record-breaking material discovered last year by Swedish researchers has passed another milestone for drug delivery, showing it can hold poorly soluble drugs and, down the road, deliver them with a fast dissolution rate.
Over the past two decades, 3-D printing has grown from a niche technology to a multibillion-dollar industry. The manufacturing process was developed in the 1980s as a way to produce small volumes of scale models but has since expanded to include the manufacturing of medical devices and implants for surgical and clinical use. The process, also known as additive manufacturing, uses computer models to build three-dimensional objects by printing materials like plastic, polymers, metals and powders in layers.
Acne remedies and ADHD drugs are big markets for the teen demographic — but how exactly are young consumers interpreting advertisements for these products? A soon-to-launch FDA study aims to find out exactly that.
The Centers for Medicare & Medicaid Services propose 4 changes to physician payment transparency rules that could mean major new costs for medical device makers.