2014 BLA approvals by US FDA: time requiredHere's a little tidbit for a Saturday morning.
In addition to the >100 drugs approved by the FDA last year is a much shorter list of 11 "BLA drugs".
Of the eleven, eight were reviewed on a priority basis.
With a little poking around you can come up with the application date when the Biologics License Application (BLAs) was filed for each of these.
From the earliest to latest applicant, approval took the following time (in months):
11.5, 23, 8, 8, 11, 6, 6, & 5.
Takeaway: FDA seems to be turning these around a bit faster.
No info on how many applied under BLA and didn't make it; so, no word on the odds of success.
Cheers,
QA
Link to complete list of drugs approved by FDA in 2014:
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM435753.pdf