"Lagging Indicators": Is There A "Drug Lag" Between U.S. And Europe?
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's John Jenkins discusses concerns about return of the "drug lag" during IoM meeting on drug safety.
You may also be interested in...
Comparing EU Vs. US Accelerated Pathway Approval Times Makes Senior UK Regulator 'Slightly Defensive'
Record-setting US Blincyto approval is case in point for discussion; EMA/MHRA official Robert Hemmings says EU review structure taps into expertise from "the whole of the continent," plus rapporteurs' independent views.
Despite European Nod, Novartis Gets FDA "Complete Response" For Indacaterol
FDA requests additional dosing information for the chronic obstructive pulmonary disorder drug, also known as QAB149.
Despite European Nod, Novartis Gets FDA "Complete Response" For Indacaterol
FDA requests additional dosing information for the chronic obstructive pulmonary disorder drug, also known as QAB149.