New FDA Regs/Antibodies

Phillip E. Schwartz schwartz at bioreagents.com
Thu Jul 11 14:49:48 EST 1996


Please help!

Will the individual at your organization who is in charge of regulatory 
affairs or who is concerned about the negative effects new FDA 
regulations may have on basic scientific and medical research in addition 
to health care in general please contact me regarding this matter. I am 
trying to get as many people to comment on and become involved in a 
grass-roots effort to keep the FDA from including all antibody research 
reagents as ‘in vitro diagnostic devices’. Granted, some are but most are 
not. Please review the information at:

http:/www.earthnet.net/~affinity/fda/

It would be optimal if this website could be hotlinked to yours to gain 
the maximum amount of exposure prior to August 30, 1996 public comment 
deadline. I would appreciate any comments, questions, referred contacts, 
etc. that may be useful in changing the language of this pending FDA 
regulation.

<Excerpt from webpage:
We wanted to bring to the attention of the biological research community 
recent FDA regulations which will likely have the chilling effect of 
curtailing the availability of monoclonal and polyclonal antibodies in 
the U.S. and consequently hindering the US researchers competitive 
position with respect to those in other countries.>

FDA Regulation:
The Immunohistochemistry Reagents and Kits Regulation: 21/CFR 864
Docket Number: 94P-0342

Sincerely,

Phillip E. Schwartz
Antibody Partnership Project Manager

Affinity BioReagents, Inc.
14818 W. 6th Ave., Suite 13A
Golden, CO 80401
TEL:		800-527-4535
FAX:		303-278-2424
email:		schwartz at bioreagents.com
website:	http://www.bioreagents.com/affinity



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