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)