The cost of treating cancer has increased over the past few years—there’s no denying that. But there’s more to that increase than meets the eye. In other words…it is not just about prices.
The medical device industry appears to be under siege by cybercriminals; however, it is not taking steps to defend itself, according to two separate reports.
During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for it’s pricing. Now, his new FDA Commissioner is laying out some approaches the agency will take to fight high prices.
The U.S. Food and Drug Administration (FDA) announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced today the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico.
As an Agency dedicated to promoting public health, and as fellow Americans, the staff at the U.S. Food and Drug Administration (FDA) is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. First and foremost, these efforts are focused around our mission driven responsibilities to ensure the safety of the medical products, blood and the food supply needed by residents of the island. Our efforts also encompass challenges that are unique to Puerto Rico. The island is home to a substantial base of manufacturing for critical medical products that supply the entire world. This industrial base is an important source of jobs and economic vitality for the island. It is a key to Puerto Rico’s economic recovery. The manufacturing facilities are also a pivotal source of critical medical products for the entire United States. Helping to bring these resources back in operation is an important goal of ours and of Puerto Rico’s.
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — and creating three new geographic divisions for oversight of devices.
Scientists at Rutgers University-New Brunswick have created a graphene-based sensor that could lead to a wearable device that when blow into predicts the likelihood of an asthma attack.
Researchers have used data gathered by connected thermometers to predict the onset of an influenza outbreak. An analysis of data from users of the iThermometer wearable and its companion app in China predicted the spike in the 2015-16 flu season one month before the country’s public health body.
Pharma reps may soon have to cancel any doctor dinners they have planned in California. A state-level bill would cut off most drugmaker payments to physicians, including speaking fees for that staple of pharma marketing, the slideshow, over dinner.
Scientists at Sanford Burnham have identified the mechanism that causes muscle cells to stop regenerating as people age. This knowledge could lead to methods to slow — but not stop — the decline in muscle mass and function people experience as they get older.