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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...

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