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The Caribbean Cytometry & Analytical Society (CCAS) has opened their official society website. Click here to visit the CCAS site.
Upcoming Meetings
CCS 2010
October 1-5 2010
Houston, TX
ANNOUNCEMENT:
After the regulatory affairs session at the last meeting there was some confusion about the new FDA guidance document regarding the production of antibody"cocktails". Specifically, it was not clear to many whether the sentiments in that document applied to individual laboratories making their own cocktails of ASRs purchased from manufacturers. I had a discussion with Dr. Steven Gutman, director of the in vitro diagnostics device division at FDA, and he clarified the situation and approved the following statement: There is no intent for the FDA position to apply to individual laboratories, or to prevent them from making cocktails; laboratories have the responsibility to validate the use of ASRs as components of laboratory assays, but they are free to do this validation using either individual ASRs or cocktails that they themselves assemble, depending upon their laboratory practice. There is no requirement that a laboratory making such cocktails submit any documentation on their performance to the FDA.
At the same time, he made it clear that manufacturers WILL have responsibility for FDA submissions if they are going to continue to market antibody combinations. We are exploring ways in which CCS can help manufacturers with these submissions.
Society Journal