EMA's Proposal To Disclose Key Elements Of Pediatric Plans On Hold For Now
Executive Summary
A year after the European Medicines Agency announced plans to publicly disclose the key elements of pediatric investigation plans to make its regulatory decisions more transparent, concerns around confidentiality issues and resources means no final decision has yet been made on the implementation of this controversial proposal.
You may also be interested in...
A Whistle-Stop Tour of 2017 – From An EU Regulatory Point Of View
This past year was a busy one for regulators and regulated alike in the EU. We take a look at some of the key events from 2017.
A Whistle-Stop Tour of 2017 – From An EU Regulatory Point Of View
This past year was a busy one for regulators and regulated alike in the EU. We take a look at some of the key events from 2017.
EU Regulatory Review – What Pharma Should Remember From 2017
You could be forgiven for thinking that Brexit was the only story in town on the European regulatory front in 2017, but there were of course plenty of other important developments during the year.