NEW YORK (GenomeWeb News) — The US Food and Drug Administration has just released a draft guidance covering submission regulations for diagnostics developers seeking approval for Class III in vitro diagnostic devices.
 
The guidance proposes a set of updates that FDA believes would create a less burdensome regulatory path to approval for a previously approved or licensed assay that is being migrated for use with another system for which it has not been approved.
 

To read the full story....

Register for Free.

...and receive Daily News bulletins.

Already have an account?
Login Now.

In a statement, National Institutes of Health Director Francis Collins says sexual harassment is "morally indefensible" and "unacceptable."

Octopuses might owe their intelligence to their liberal alterations to their genes, Cosmos reports.

Stat News and ProPublica report that African Americans are underrepresented in cancer clinical trials.

In Cell this week: genomic analysis of abdominal aortic aneurysm, effect of probiotics on the microbiome, and more.