Gastrointestinal Drugs Advisory Committee (GIDAC) in joint session with the
Drug Safety and Risk Management Advisory Committee (DSaRM)
July 31, 2007
Portions of this document have been determined to be exempt
from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §
FDA Briefing Material (pdf)
Addendum (ppt) (htm)
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.
TYSABRI (natalizumab), BIOGEN IDEC, Inc.
Briefing Material (pdf)