economic analysis of new diagnostic kits - (Jan/23/2005 )
Hi,
we've all heard how expensive and time consuming it is to bring a new drug to market....
does anyone know if there is information "out there" on how expensive and time consuming it is to bring a new diagnostic kit to market?
any ideas on journals?
so very verrrry stuck on this (damn my project. damn it to hell).
vetticus
If the kit is intended for human use, it has to be approved by FDA. don't know how long it takes.
going to be a pain in the bum right now....but... did you know that a diagnostic kit can be sold to a clinical path lab with a "for research purposes only" label on it, so long as the clinical path lab is willing to add in one of their own homebrew reagents... thereby cutting the cost of FDA approval and red tape and yeah... i leant something today...me happy.
mmm homebrew
actually, if anyones interested in this at all (if you are, then get a life!!! i keed, i keed), i just got a e-mail today from a head anatomical pathologist, who said that, with regard to making up a path report, is "mish mash". ie nothing is standardised, different departments in hospitals have their own path people, and yeah...
back to the point.... thanks