EMA Transparency Gathers Pace With A Flexible Definition Of Confidential Information
This article was originally published in The Pink Sheet Daily
Documents not already in the public domain would not be released under EMA's definition of commercially confidential information, which is designed to be wide-ranging and flexible enough to address pharma's concerns.
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.
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.
Statistical analyses based on pivotal trial data and used to promote a drug must prove what they purport to prove, FDA's Office of Prescription Drug Promotion says in an NOV letter to Otsuka over a website for the leukemia drug Busulfex (busulfan).