Subscribe
  
IPQ Inside the global regulatory dialogue

FDA Deploys Risk Ranking Process to Streamline ANDA Review

Jun 29th, 2014

Please Log in to print the full article

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.

[The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/licensing information, click here.]

Pages: 1 2

    ©2021 IPQ Publications