FDA TO REGULATE RESEARCH ANTIBODIES

James Stiehr jstiehr at bioreagents.com
Mon Jul 1 11:17:42 EST 1996


The FDA has just proposed new regulations on the sale and distributions 
of antibodies and other reagents which will result in the withdrawal of 
many research reagents from the US market.  The net result of these 
regulations is the reduction of tools available to the US research 
community (non-US researchers will still have access to these tools).

The “Research Use Only” disclaimer WILL NOT prevent the FDA from removing 
many reagents from the market if suppliers do not treat antibodies as In 
Vitro Diagnostic Devices, submitting them to FDA for review, approval and 
oversight.

For a more thorough review of the issue as well as the regulations 
themselves, a special web page has been set up as an educational 
resource.  Visit http://www.earthnet.net/~affinity/fda for an overview of 
the issues, the proposed regs, and what you can do about them.

Protect your access to these critically important research tools!  Act 
today!

James Stiehr
Affinity Bioreagents, Inc.



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