According to a Government Accountability Office (GAO) report, FDA was inconsistent in its review of pre-market approval applications. These findings were based on the years starting in 2003 and ending in 2010. The report also said FDA was “especially” inconsistent with applications marked “expedited”. In addition to inconsistency, the report also found that 510(k) submission times had increased 61%, from an average of 100 days to 161 days between 2005 and 2010, although the FDA still met performance goals for those applications. To read more, click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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