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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the December 4, 2012 Meeting of the Oncologic Drugs Advisory Committee

 

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance
 
 
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 for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 100KB)
 
Errata to the FDA Briefing Information for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 27KB)
 
 
GlaxoSmithKline, LLC
 
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.
 
GSK Briefing Information for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 113KB)
 
Errata to the GSK Briefing Information for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 108KB)
 
 
Threshold 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.
 
Threshold Briefing Information for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 265KB)
 
 
Boehringer Ingelheim 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.
 
Boehringer Ingelheim Briefing Information for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 292KB)
 
 
Amgen, 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.
 
Amgen Briefing Information for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 480KB)