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.
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.
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.
US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating
FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.