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Food and Drug Administration

Pediatric Advisory Committee

November 29, 2007

BRIEFING INFORMATION

FDA

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.

Cover Memo (pdf)

Supplemental Cover Memo (pdf)

Supplemental Background Memorandum (pdf)

Guidance Document (pdf)

Code of Federal Regulations Title 45 (pdf)

Page last updated November 26, 2007 kkhorizonal rule
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