FDA Told U.S. Drug System Is Broken (Washington Post)
The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.

OraSure Technologies Commences Initial Studies for FDA Approval of Home Use Rapid HIV Test Kit (Business Wire via Yahoo! Finance)
BETHLEHEM, Pa.----OraSure Technologies, Inc. , the market leader in oral fluid diagnostics and the manufacturer of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, announced today that it has commenced several laboratory-based operational studies as the initial stage of the process to obtain U.S.