US FDA's Generics Program Reaches 'Steady State' Milestone
Executive Summary
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.
You may also be interested in...
Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels
Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.