The ongoing overhaul of the generic drug review process has frustrated generic drugmakers in India. The country's $15 billion pharmaceutical industry supplies around 40 percent of generic drugs in the United States. There is a backlog of applications due to an increased number of generic drug applications from foreign facilities, concerns about adequate inspection of production facilities before final approval, and FDA's limited resources. FDA is aiming to improve the current review time of 30 months to 10 months by 2017, beginning with a 15-month target review time for at least 60 percent of the applications submitted in the year beginning October 2014.
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