July 24, 2007
BREIFING INFORMATION
Seating in Room 1066 of the Advisors and Consultants Conference Room will be limited. Additional seating will be available in Room 1004, where the meeting
may be viewed on live video cast.
No other changes have been made to this meeting.
Morning Session
Eli Lilly & Co
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.
Evista (raloxifene Hcl) Eli Lilly & Co
Indication: Invasive
Breast Cancer Risk Reduction (pdf)
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)
Errata (htm)
Afternoon
Session
GPC Biotech,
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.
Orplatna (satraplatin capsules) GPC Biotech, Inc
Indication: Treatment of men with androgen-independent
(hormone refractory) prostate cancer that has failed prior chemotherapy (pdf)
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)