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GDUFA Research Impacting Generic Development, ANDA Approvals

 
• By Derrick Gingery

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

drug discovery research
Bioequivalence method research has helped sponsors obtain ANDA approvals. • Source: Shutterstock

US Food and Drug Administration regulatory science research is beginning to pay off in generic drug approvals.

Office of Generic Drugs data shows ANDA approvals directly related to research projects conducted through the generic drug user fee research program steadily increased from fiscal year 2018 through fiscal...

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