FDA’s generics office has developed a risk assessment algorithm for the review of abbreviated new drug applications (ANDAs) to help address the challenges of balancing more extensive quality-by-design-based submissions with the foreshortened review timelines mandated under the Generic Drug User Fee Act (GDUFA).
At a Generic Pharmaceutical Association (GPhA) CMC Workshop in early June in Bethesda, Maryland, Office of Generic Drugs (OGD) Chemistry I Division Director Andre Raw described the risk-based review process that OGD has now instituted for ANDAs.
In his presentation, Raw covered: ● the drivers for the new risk-ranking approach ● how OGD’s question-based review (QbR) and quality-by-design (QbD) efforts helped inform it ● how it was developed ● how it works ● success to date, and ● future plans, which include the application of the concepts in the new drug arena.
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