FDA Advisory Committee to Review DOR BioPharma's orBec(R) for the Treatment of GI GVHD (Market Wire via Yahoo! Finance)
DOR BioPharma, Inc. announced that it has received notification from the U.S. Food and Drug Administration that the Oncology Drug Advisory Committee ("ODAC") will review the New Drug Application for orBec for the treatment of gastrointestinal Graft-versus-Host disease on May 9, 2007. The FDA has previously said it will respond to DOR's NDA by July 21, 2007 in accordance with the Prescription ...

FDA Revamps Process for Safety of Drugs After Approval (Washington Post)
The Food and Drug Administration said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.

Panel Recommends That FDA Not Create Specific Effectiveness Standard For Oral Contraceptive Approvals (Medical News Today)
A panel of gynecologists, researchers and other medical experts on Wednesday at the end of a two-day meeting convened by FDA recommended the agency not set a specific standard of effectiveness for approval of oral contraceptives, the AP/Minneapolis Star Tribune reports (Bridges, AP/Minneapolis Star Tribune, 1/25). [click link for full article]