Generic Drugs: Machine Learning Modeling Can Better Predict ANDA Submissions
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.
You may also be interested in...
US FDA Begins Building Pharma Industry Activity Prediction Tool
Algorithms are intended to help predict incoming workload, which will be used to help set user fees.
US FDA Wants To Predict ANDA Complete Response Responses
Generic industry, FDA discuss potential ways to increase transparency so agency can better estimate when – and even whether – an ANDA receiving a complete response will be returned.
Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations
Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.