Warning Letter Roundup & Recap – March 1, 2016
This article was originally published in The Gray Sheet
No quality- or premarket-related device warning letters were released by FDA this week.
You may also be interested in...
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.
Dr Reddy’s sees its Indian domestic market and China as hot prospects as it pursues its “transformation journey” in which it is reducing its dependence on the slowing US market.