Able Labs Recall of All Marketed Products Boosts 2005 Recall Total
This article was originally published in The Pink Sheet Daily
Drug recall totals for 2005 show the impact of FDA findings of serious GMP and data integrity problems at Able Labs, which resulted in the recall of all of the firm's marketed products and the closing of its operations.
You may also be interested in...
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
With an unrestricted label and once-daily dosing, rivaroxaban will do battle with Boehringer-Ingelheim's dabigatran, which is dosed twice a day but can claim superior efficacy to warfarin in the atrial fibrillation population.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.