Gen-Probe Responds to FDA Questions on TIGRIS(R) / West Nile Virus Regulatory Application (FinanzNachrichten)
SAN DIEGO, Sept. 20 /PRNewswire-FirstCall/ -- Gen-Probe ( Nachrichten ) has submitted to the U.S. Food and Drug Administration (FDA) responses to the FDA's questions on Gen-Probe's regulatory application to run the previously approved PROCLEIX(R) WNV (West Nile virus) assay on the investigational, fully automated PROCLEIX TIGRIS(R) system, the Company announced today.

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.

Oscient Pharmaceuticals Receives Approvable Letter From FDA for FACTIVE(R) Tablets for Five-Day Treatment of (RedNova)
Oscient Pharmaceuticals (Nasdaq: OSCI) has received an approvable letter from the U.S.