Major letters were just posted on FDA's web site for Navigenics, Illumina, 23andMe, Knome, and deCODE. Pathway got theirs in May.
I suspect this is just the beginning. More details any day now, I'm sure.
Tags: Enforcement, FDA, LDTs
Major letters were just posted on FDA's web site for Navigenics, Illumina, 23andMe, Knome, and deCODE. Pathway got theirs in May.
I suspect this is just the beginning. More details any day now, I'm sure.
Tags: Enforcement, FDA, LDTs