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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee

 

Note: The briefing materials posted below are unchanged from the briefing materials posted for the originally scheduled (February 10, 2010) Oncologic Drugs Advisory Committee meeting on these same two topics.

 

Morning Session

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 Information, Pixuvri (Pixantrone), for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee (PDF – 163KB)

 

Cell Therapeutics, 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.

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance

Cell Therapeutics Briefing Information, Pixuvri (Pixantrone), for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee (PDF – 2.0MB)

 

 Afternoon Session

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 Information, Omacetaxine (Omapro), for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee (PDF – 438KB)

 

ChemGenex Pharmaceuticals, 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.

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance

ChemGenex Pharmaceuticals Briefing Information, Omacetaxine (Omapro), for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee (PDF – 333KB)

ChemGenex Pharmaceuticals Briefing Information- Errata 1, Omacetaxine (Omapro), for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee (PDF – 57.3KB)

ChemGenex Pharmaceuticals Briefing Information- Errata 2, Omacetaxine (Omapro), for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee (PDF – 95KB)