In Manufacturing, Absence Of Evidence Is Not Evidence Of Absence, FDA Tells BioMarin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
BioMarin showed that the Vimizim BLA did not have enough data to prove that clinical and commercial sites are different. That’s not the same as concluding there is no difference between the sites, FDA said.
You may also be interested in...
As Orphan Drugs Gain More Attention, FDA Releases Development Guidance
Straightforward draft document seems aimed at entities that have limited experience working with the agency.
Review Of Reviews: Drug Review Profiles 2014
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.
Review Of Reviews: Drug Review Profiles 2014
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.