Pluristem Therapeutics Files an IND Application with the FDA to Initiate a Phase I Clinical Trial Utilizing PLX-PAD ... (Centre Daily Times)
Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical trials with its placental-derived stromal cell product, termed ...

Report: FDA Speeding Approvals Of Medical Devices (KOLR - KSFX Ozarks)
The Food and Drug Administration is coming under fire from within over its quick approvals for controversial devices. "The New York Times" is reporting that more than three-thousand medical devices sailed through the easiest level of the approval process in 2007.

FDA Advisory Committee Unanimously Recommends Sabril(R) (vigabatrin) For The Treatment Of Two Catastrophic Epilepsies (Medical News Today)
OVATION Pharmaceuticals, Inc. announced that the Peripheral and Central Nervous System Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) voted unanimously (23-0) to recommend Sabril (vigabatrin) as a monotherapy for Infantile Spasms (IS).