Posted by Michael Wonder on 06 Apr 2017
Regulatory review of new therapeutic agents — FDA versus EMA (2011–2015)
6 April 2017 - The FDA faces continual pressure to accelerate the regulatory review and approval of new medicines.
Although the 21st Century Cures Act, which was signed into law in December 2016, includes several reforms that are intended to further streamline FDA evaluations, the speed of the regulatory review process is directed by the Prescription Drug User Fee Act (PDUFA).
With Congress poised to consider the reauthorisation of the PDUFA before it expires in October 2017, the speed of the FDA regulatory review process will come under renewed scrutiny. To inform these discussions, Downing et al. compared review times for new therapeutic agents that were approved by the FDA or the EMA, the primary drug regulator in Europe, between 2011 and 2015.
