FDA TO REGULATE RESEARCH ANTIBODIES

Bryan Kiehl b3748 at cts.com
Mon Jul 1 23:55:11 EST 1996


See bionet.diagnostics for discussion.

James Stiehr <jstiehr at bioreagents.com> wrote:

>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.

Bryan Kiehl
GenBio
GenBio at msn.com
San Diego, CA




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