The US FDA is expecting ANDA submissions to decrease in fiscal year 2019, which translated into a significant increase in the cost to file them.
The ANDA filing fee will increase to $178,799 in FY 2019, a jump of nearly $7,000 from FY 2018. It...
ANDA Submissions To US FDA Expected To Decline; Generic User Fees For FY 2019 Will Rise
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FDA's predictions have been pretty consistent; actual submissions haven't been.
Learn what's happening at the US FDA. On the go.
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