ANDA Submissions To US FDA Expected To Decline; Generic User Fees For FY 2019 Will Rise

 
• By Derrick Gingery

FDA's predictions have been pretty consistent; actual submissions haven't been.

Medicine pills or capsules with money, dollar. Medical or pharmacy prescription for health. Business, finance concept. Cost of the healthy life. Bottle of drug or vitamin for currency.

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...

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