FDA TO REGULATE RESEARCH ANTIBODIES
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
>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
>Affinity Bioreagents, Inc.
GenBio at msn.com
San Diego, CA
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