Re: Package Insert Labels for Radiopharmaceutical Imaging Agents

[carol marcus <csmarcus@ucla.edu>]

At 05:02 PM 3/7/00 -0600, you wrote:
>
>--Boundary_(ID_rRUHD/sWGGb6tEtGMgpKTA)
>Content-type: TEXT/PLAIN
>
>Dear Radsafers,
>
>I need a desktop reference that contains the Package Insert Labels for
Medical Diagnostic Imaging Agents.  Does such an animal exist?  I am
picturing something like the Physician's Desk Reference.
>
>Please respond to me directly if you have any information.
>
>Thank you!
>Wade Sewell
>wade.a.sewell@dupontpharma.com
>
>--Boundary_(ID_rRUHD/sWGGb6tEtGMgpKTA)--
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Dear Wade and Radsafers:

The PDR has not included radiopharmaceuticals for about 25 years; ditto for
contrast agents.  However, these drugs have monographs in the USP.  The USP
monograph is much more extensive than the FDA package insert, and indicates
which medical indications are approved by the USFDA, the Canadian
equivalent, and then other indications  supported by scientific and clinical
work, determined by experts in the field.  The chemistry standards are in
USP 24 (2000); the Drug Information (USP-DI) volume is complete for 1999 but
abridged in 2000 with monographs left out available by special request. The
nuclear medicine community is hoping to get the USP-DI available on line.

If you have specific questions, I will try to help you.

Ciao, Carol

Carol S. Marcus, Ph.D., M.D.
<csmarcus@ucla.edu>

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