RAPS: Generic Drug Review Dashboard: FDA Offers a First Look

As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs). What’s clear from the new data on 2015 is that FDA continues to seek more information or require companies to correct what’s known as an “easily correctible deficiency” for the vast majority of ANDAs. And in case the ANDA approval process seems to be nothing more than a formality, the statistics show that FDA is actually rejecting far more ANDAs than it’s approving. In fact, for one-third of 2015, or four months, FDA rejected more than twice as many ANDAs as it approved.