GDUFA fees for 2020 have been decided – and include a significant drop in the fees for finished dosage facilities.
Stephanie Sutton | | Quick Read
Generic Drug User Fee rates for fiscal year 2020 (beginning October 1, 2019) have been published by the FDA (1). The fees specify what companies must pay for Abbreviated New Drug Applications (ANDA), Drug Master File (DFM) submissions, annual active ANDA holdings, and API and finished dosage form facilities. Compared with the previous year, the fees for Finished Dosage Form (FDF) facilities have dropped by around 6 to 7.4 percent.
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