Diana:

FDA's site is
http://www.fda.gov

However, the applicable rules may be hard to track down there.  Try going to
the public bulletin board at JCIM's web site:
http://www.jcim.org

The JCIM site should have all the relevant recent rules, summaries, and
commentary applicable to IHC and other immuno and molecular biology reagent
requirements.

Peter
--
Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
STEREOTAXIS, Inc.
Ph. 1-314-615-6964; Pager: 841-9351
ptakes@stereotaxis.wustl.edu

Diana Goodwin wrote:

> Hi, Netters.
>
> Can someone please direct me to a source for the new FDA rulings on
> primary Ab's for IHC?  Is there a web page for the FDA?  I need to print
> out the official ruling to give to my pathologists.
>
> Thanks!
> --
> Diana Goodwin, HT
> Trenton, NJ