Taking Auditing to New Level with International Standard Under Revision
ISO’s popular standard for auditing management systems is under revision and has just reached the first voting stage, a crucial step in its development.
Month: October 2017
Drugmakers ‘hijacked’ the FDA’s orphan system to score premium pricing on mass-market meds: report
There is no denying that financial incentives for orphan drug development spawned meds that have saved hundreds of thousands of lives. However, they have also helped mass-market drug makers rack up millions in incentives, tax breaks and patent-protected profits — in some cases through monopoly pricing, a new report contended.
In the midst of a deadly opioid crisis, Ohio sues drugmakers for marketing fraud
After seeing drug overdoses become the state’s leading cause of accidental deaths, officials in Ohio have had enough. In a new lawsuit filed in May, Ohio Attorney General (AG) Mike DeWine is going after Teva, Allergan, Johnson & Johnson, Purdue and Endo for alleged “fraudulent marketing practices” on powerful opioid painkillers.
Cancer costs are up–but there’s more to the story than rising prices, report says
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.
Medical device industry ‘not doing enough on cybersecurity’
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.
New FDA commissioner Gottlieb unveils price-fighting strategies
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.
FDA selects participants for new digital health software precertification pilot program
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
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.