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Generic Drugs: Machine Learning Modeling Can Better Predict ANDA Submissions

 
• By Sue Sutter

US FDA staff describe their experience with a method that accurately predicted the time to first submission of generic drug applications for new chemical entities; this approach could help the agency optimize resource allocation and workload under the generic drug user fee program.

Concept about machine learning to improve artificial intelligence ability for predictions - Image
FDA researchers tested the ability of a machine learning approach to predict ANDA submissions. • Source: Shutterstock

A machine learning modeling approach that leverages drug product, regulatory and pharmacoeconomic information can accurately predict the time to the first abbreviated new drug application submission for a new chemical entity, US Food and Drug Administration researchers report.

This modeling approach could help the agency optimize its resource allocation and workload under the generic drug user fee program to inform strategic planning for guidance development and presubmission meetings,...

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