FDA reports back on 2019 generics progress
The US Food and Drug Administration (FDA) has published a report on its progress in the generic drug development space during 2019.
In order to assist the drugmakers behind these affordable medicines, the Generic Drug User Fee Amendments of 2012 (GDUFA) established a formal regulatory science program and funded research activities for investigating new methodologies and tools for their development.
The GDUFA was reauthorized in 2017 through 2022 under the name GDUFA II. The latest report elaborates on the results of these efforts in 2019, which marks the second year of GDUFA II.
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