Food and Drug
Administration
Oncologic
Drugs Advisory Committee
Briefing Information
September 6, 2006
Morning Session
Genta Incorporated
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.
Genta, Inc. Briefing Material for Genasense (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).
These redacted portions will appear as white space on the
screen or on the printed page.
FDA Briefing Material for NDA 21-874 (pdf)
Afternoon Session
Pfizer, Incorporated
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.
Pfizer, Inc. Briefing Material for Fragmin (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).
These redacted portions will appear as white space on the
screen or on the printed page.
FDA Briefing Material for NDA 020-287 (pdf)