ANDA Approval Speed-Up Leaves Sponsors With Less Margin For Error
Executive Summary
Get applications in right, or get a complete response letter, FDA says; firms will have fewer opportunities for mid-review application corrections as review goals reach 10 months.
You may also be interested in...
ANDA Sponsors Need To 'Slow Down' And Focus On Quality, US FDA Generics Director Says
Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.
ANDA Sponsors Need To 'Slow Down' And Focus On Quality, US FDA Generics Director Says
Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.
Sentinel May Expand To Generic Equivalence Studies
Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests:
