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Cardiovascular and Renal Drugs Advisory
October 16, 2007
Regulatory considerations for extending
the use of phosphate binders to the pre-dialysis population.
The statements contained in this document(s)
are those of the product's sponsor, not FDA, and FDA does not necessarily agree
with the sponsor's statements. FDA has not made a final determination about the
safety or effectiveness of the product described in this document.
FRESENIUS MEDICAL CARE NORTH AMERICA AND SHIRE PHARMACEUTICALS
Briefing Document (pdf)
The FDA has no formal
briefing document for this Advisory Committee meeting