Managing Clinical Data For Worldwide Acceptance (Medical Device Link)
Medical device clinical studies are conducted to generate data regarding the safety and performance of a device. Often, these data are needed for marketing authorisations in countries that have varying regulatory requirements such as the United States (US), Europe and Japan.

FDA Approves New, Once-a-day COREG CR For The Treatment Of Three Key Cardiovascular Conditions (Medical News Today)
GlaxoSmithKline (NYSE: GSK) and Flamel Technologies (NASDAQ:FLML) today announced FDA approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules, for the treatment of three cardiovascular conditions: -- High blood pressure, also known as hypertension. [click link for full article]