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Food and
Drug Administration
FDA Advisory
Committee Briefing Document of the Drug Safety & Risk Management Advisory
Committee (DSaRM)
February 1, 2008
FDA
Disclaimer
Portions of this document have been determined to be exempt
from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §
552).
FDA Briefing Material (pdf)
Bibliography (pdf)
Errata (pdf)
Luitpold
Pharmaceuticals, Inc
Disclaimer
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.
Briefing Material (pdf)