Gilead Sciences Refiles New Drug Application With The FDA For Single-Tablet Regimen Of Truvada(R) And TMC278
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults ...

FDA aims to accelerate medical device reviews - Sun, 13 Feb 2011 PST
WASHINGTON Federal health officials are proposing a plan that would speed up the approval of innovative medical devices that have the potential to dramatically improve patients lives. The so-called Innovation Pathway, announced last week by the Food and Drug Administration, would aim to review first-of-a-kind devices in five months, which is half the time currently spent reviewing most new ...