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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the October 5, 2009 Meeting of the Oncologic Drugs Advisory Committee

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 Material (pdf)

Errata (pdf)

 

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Schering-Plough Corporation

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.

 

PegIntron® (Pegylated Interferon Alfa-2b) as Adjuvant Treatment of Stage III Melanoma (pdf)

 

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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 Material (pdf)

Errata (pdf)

 

***************

 

GlaxoSmithKline

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.


VOTRIENT™ is indicated for the treatment of patients with advanced renal cell carcinoma (pdf)

Addendum (pdf)