Regulatory/Legal
Jun 25, 2007
Bloomberg News reports that the Supreme Court
Jun 25, 2007
Medical devices are designed and tested for adults. How to use them in children -- and whether additional studies are required -- is a problem that has vexed...
Jun 22, 2007
AdvaMed has announced a universal healthcare plan that would give all Americans the option of buying health insurance at an affordable price. Approved...
Jun 21, 2007
Health care reform is traditionally considered the province of politicians, bureaucrats, doctors and other caregivers, insurance companies, and consumers. But...
Jun 15, 2007
Did you know that CDRH can regulate your outsourcing arrangements? Well, it can, and attendees at the MD...
Jun 06, 2007
FDA this week announced the formation of a 15-member committee to advise it on how to improve communication regarding risks and benefits of medical devices and...
Jun 05, 2007
Dr. Steven Nissen, head of the Cleveland Clinic's department of cardiovascular medicine, has made a name for himself as an FDA watchdog in recent years. He was...
May 31, 2007
A federal judge refused to grant Shelhigh Inc.'s request that the government release the tissue-based devices it seized last month because of concerns about...
May 30, 2007
James Mazzo, president and CEO of Advanced Medical Optics, told the media that the recall of its contact lens solution is not related to a manufacturing...
May 29, 2007
FDA announced late last week that Advanced Medical Optics (Santa Ana, CA) has voluntarily recalled its Complete MoisturePlus Multi Purpose Solution for soft...