I've had a long held view that although CLIA labs don't need FDA approval, the litigious nature of the US suggests to me that they wouldn't go ahead without international regulatory approval. It just makes it easier to justify if sued. So I think TGA is critical, but not technically necessary, for the CLIA contract award. My theory only.
Holiday Research - US competitive landscape and pan-cancer detection, page-10
-
- There are more pages in this discussion • 15 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
