FDA Recommends Separate Manufacturing For Sensitizing Non-Penicillin Beta-Lactams
This article was originally published in The Pink Sheet Daily
Executive Summary
In comments on the draft guidance, though, some firms want clearer strictures from the agency, while others seek more flexibility.
You may also be interested in...
Is Ranbaxy Inching Closer To Resolution Of Its GMP Disputes With U.S. FDA?
MUMBAI - After more than two years of serious deliberations, Ranbaxy seems to be finally moving forward to resolve charges of significant manufacturing lapses leveled by U.S. FDA at two of its India-based sites
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
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.
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.