Nearly Half of Recent EU Approvals Based on a Single Pivotal Study
By Michael Mezher -
Published 10 November 2017
A recent study found that 45% of marketing authorizations granted in the EU from 2012 to 2016 were based on evidence from a single pivotal trial.
Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy
Tags: Pivotal Trials, Single Pivotal Study