I am sure Pasaca/innova are not concerned by a lit
Post# of 22456
"They are in the FDA’s dog house"
There is no FDA dog house asjk these guys their weren't discouragedl after suffering the raft of the FDA and US government.
https://violationtracker.goodjobsfirst.org/parent/pfizer
Quote:
Abbott Laboratories is to pay a $100 million fine to the US government and temporarily suspend the manufacture of 125 types of its diagnostic devices after reaching agreement with the US Food and Drug Administration, which has been questioning quality control at Abbott's plant in Lake County, Illinois (Marketletter ...
Quote:
Glaxo's $3 billion settlement included the largest civil, False Claims Act settlement on record, and Pfizer's $2.3 billion settlement including a record-breaking $1.3 billion criminal fine. ..
If anything the setback from the FDA should strengthen the Pasaca/Innova/QMC relationship not weaken it.
With the failure to get their current test approved, Pasaca/Innova should be more encouraged then ever to have QMC help developed the next generation in diagnostic testing that would meet FDA accuracy guidelines..