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The US Food and Drug Administration (USFDA) has has hiked fee for processing Abbreviated New Drug Application (ANDA) by over USD 1 lakh to USD 1.71 lakh for the fiscal year 2018.
The hike has been made under Generic Drug User Fee Amendments of 2017 (GDUFA II).
In FY17, the fee has been USD 70,480.
FDA has said in a statement that “The FY 2018 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2018 (948) into the fee revenue amount to be derived from ANDA application fees in FY 2018 (USD 162,888,000). The result, rounded to the nearest dollar, is a fee of USD 171,823 per ANDA.”
