“Breakthrough” Designation: FDA Clarifies How To Get It – And How It Can Be Lost
This article was originally published in The Pink Sheet Daily
“Preliminary clinical evidence” should demonstrate substantial improvement in effectiveness or safety over available therapies but likely will not be sufficient to support approval, final guidance explains.
You may also be interested in...
After Pandemic, US FDA Commissioner Wants To Continue ‘Rolling Review’ Offered To COVID-19 Products
Stephen Hahn also said the expedited approval process could be even more efficient.
GSK's Tafenoquine Faces Questions Over Review Pathways At US FDA Panel
Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.
Supplemental Oncology Approvals: 'Reverse Accelerated Approval,' Not Lowering The Bar
Sometimes data supporting drug's initial approval can serve as confirmatory evidence for full approval of a subsequent indication based on an intermediate endpoint, US FDA Oncology Center of Excellence Director Pazdur says; proposed framework discussed at Friends of Cancer Research meeting would establish more systematic approach to streamlining supplemental approvals.