Regulatory/Legal
Jun 29, 2006
The New York Times reports that a Sanford C. Bernstein...
Jun 28, 2006
FDA has unveiled the Human Subject Protection and Bioresearch Monitoring Initiative, which aims to modernize the regulation of clinical trials and bioresearch...
Jun 27, 2006
Four orthopedics companies announced that they have received subpoenas from the Justice Department as part of a probe into possible antitrust violations, the...
Jun 23, 2006
An FDA analysis conducted last year concluded that Guidant implantable cardioverter-defibrillators were 10 times more likely to fail than the company had let...
Jun 22, 2006
FDA's San Francisco District and AdvaMed have announced a public workshop on device regulations, geared toward assisting small and start-up manufacturers. It...
Jun 20, 2006
CDRH has been busy getting inspection-related guidance documents ready. Last week it published the latest version of its general guidance document on...
Jun 19, 2006
Acting FDA Commissioner Andrew von Eschenbach says all the right things. At last week's annual meeting of the Medical Device Manufacturers Association, he made...
Jun 13, 2006
Medtronic has received reimbursement approval in France for its Endeavor drug-eluting coronary stent system. The stent is now available in all Western European...
Jun 12, 2006
Judges are continuing to obtain more power over intellectual-property decisions affecting devices and other industries, MD...
Jun 02, 2006
Citing the lack of uniformity in the size of medical devices and their packaging, FDA a few years ago decided not to require devices to be bar-coded or...