Food and Drug Administration

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

March 14, 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 white space on the screen or on the printed page.

Memo to the Committee

Briefing Information – High Dose Methotrexate & Daunomycin

Novartis, Inc.

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.

Novartis Briefing Material for Exjade

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 Exjade

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 – Drug Shortages