A consumer advocacy group called Public Citizen is urging the Food and Drug Administration (FDA) to place black box warnings on certain medications used to treat Parkinson’s disease because...
Since its approval by the House of Representatives in July 2015, the 21st Century Cure Bill has stalled in the Senate for nearly a year. The Bill would allow...
The Food and Drug Administration (FDA) has released a draft guidance on medical device availability, compliance, and enforcement. The draft guidance will help device manufacturers understand the process the...
Although the Food and Drug Administration (FDA) was established in 1906, it wasn’t until seventy years later the FDA had the authority to classify medical devices and enforce adverse...
The Food and Drug Administration (FDA) has approved an unusual device that is designed to remove food directly from the stomach and deposit it into the toilet. While the...
Health Canada released a statement warning physicians and patients of the dangerous complications associated with Essure, a permanent birth control implant. The device, manufactured by Bayer A.G., has led...
There are two ways that the Food and Drug Administration (FDA) approves new medical devices, and which method it uses depends whether or not a device is similar to...
A recent study published in the Mayo Clinic Proceedings found that the standards for approving new cancer drugs were much lower and less effective than currently utilized treatments. The...
The European Medicines Agency (EMA) has issued a warning to European doctors urging them to stop using diabetes medication Invokana in some patients due to a recent study that...
Congress has finally agreed to provide much needed funding for the National Institute of Health, but the $8.8 billion promised comes with a price. Congress wants to make the...