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.
