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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the July 15, 2009 Meeting of the Oncologic Drugs Advisory Committee

BRIEFING INFORMATION

 

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)

Addendum (pdf)

Errata (pdf)

 

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Ortho Biotech Oncology Research & Development,

A Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C

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.

 

YONDELIS® (trabectedin) in combination with DOXIL®/CAELYX® (doxorubicin HCL liposome injection) for the treatment of patients with relapsed ovarian cancer (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)

 

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

 

Ortho Biotech Oncology Research & Development,

A Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C

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.


DOXIL® breast cancer supplemental new drug application (pdf)