As reported by Alexander Gaffney in RAPS in 2014, the Manhattan Institute of Policy Research (MIPR) claimed that the inconsistencies in review times at FDA were due to inefficiencies by the agency.
Since then, FDA has argued that the variations at the Center for Drug Evaluation and Research (CDER) were caused by accelerated review in specific areas and correlate to proportions of such.
After further data analysis of 250 new molecular entities (NME), it was found that the review time varied based on FDA prioritization of treatments, such as oncology vs. dermatology.
To read Michael Mezher’s full article, click here.