Generic Drug Research: GDUFA I Highlights
From 2013 to 2017, under the Generic Drug User Fee Amendments of 2012 (GDUFA I), the US Food and Drug Administration’s Office of Generic Drugs (OGD), through its Office of Research and Standards (ORS), awarded 36 research contracts and 69 grants for innovative research projects on generics.Divided into 18 topic areas, OGD research covered everything from how generics are perceived to abuse-deterrent formulations to modified release and ophthalmic products.
“The results from the first five years of the GDUFA regulatory science program illustrate the significant strides OGD made in addressing questions about therapeutic equivalence and the scientific evaluation of generic drug products,” OGD Director Kathleen Uhl wrote.
OGD honed in on research related to generic drug utilization and substitution, as well as locally-acting orally inhaled and nasal generic drugs.
In terms of utilization and substitution, OGD said, “Future research is needed for the development of data mining methods for secondary data sources, to help identify potential signals in the postmarketing setting. Work remains to be done exploring additional tools, such as machine learning and natural language processing, to handle more complex and unstructured data sources.”
And “the next five years of research” on locally acting orally inhaled and nasal generic drugs “will provide alternatives to comparative clinical endpoint BE [bioequivalence] studies, and a support a better understanding of in vitro, dissolution and modelling tools to be used for ANDA reviews for nasal aerosol and spray products,” OGD added.