Food and Drug
Administration
Peripheral
and Central Nervous System Drugs Advisory Committee
March 7 &
8, 2006
Briefing Information
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). These
redacted portions will appear as 'XXXX' on the screen or on
the printed page.
FDA Table of Contents
(PDF)
Tab 1. Draft Agenda (PDF)
Tab 2. Clinical Review,
FDA (PDF)
Tab 3. Statistical
review, FDA (PDF)
Tab 4. FDA Office
of Drug Safety Risk Management Action Plan (RiskMAP) Review,
FDA (PDF)
Tab 5. Questions to
Advisory Committee (PDF)
Tab
6. New England Journal of Medicine publications of Natalizumab-related
PML cases
Bibliography
(PDF)
Tab
7. Original Approved Package Insert (dated November 2004)
(PDF)
Biogen
Idec, 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)