ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19
Executive Summary
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
You may also be interested in...
GDUFA III: US FDA Says Generic Drug Supplement Volume Could Require More Resources
Will the growing workload cause GDUFA fees to increase or prompt other changes?
New AAM CEO: Traditional Lobbying On Lowering Health Care Costs Can Mix With COVID-19 Talks
Dan Leonard is working on post-pandemic generic drug issues, using coronavirus as a way to get in front of lawmakers.
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: