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loanranger

12/10/18 10:03 AM

#250874 RE: BonelessCat #250869

"A priority review can be granted at any time, including prior to Phase 1. That’s why the FDA states clinical evidence is not necessary, and it’s case by case."
(Is there a way to do that other than case-by-case"?)

As logical as that sounds it still seems inconsistent with a few other FDA statements/documents:

"When to submit request
With original BLA, NDA, or efficacy supplement"


"Priority review can be for all reviews including those between trials. It’s not just for a NDA or end-of-phase 3 review."
"Features
Shorter clock for review of marketing application (6 months compared with the 10-month standard review)"


https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf p.8
That's my source. I'd be happy to read yours.