FDA TO REGULATE RESEARCH ANTIBODIES

Bryan Kiehl b3748 at cts.com
Wed Jul 3 18:09:01 EST 1996


We are a small company too, but are in the diagnostics business and
not the research business. I do understand the requirements to comply
with GMP, but you might be surprised how this might not be so bad.

I also wonder whether you will be in trouble with FDA if you receive a
letter from the user that absolutely assures that the reagent you sell
them will not be used for diagnostic purposes. Does this allow you to
sell without FDA clearance? I'm not sure.

If there are any FDA types that wish to comment, this might help some
people.

I also suggest that this may be an appropriate forum to disucss what
GMP really does mean. There are alot of opinions, but the acutual
practices may not be so terrible. Any comments?

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




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