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Blood Products Advisory Committee

December 14, 2006

FDA Presentations

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). These redacted portions will appear as white space on the screen or on the printed page.

Review of a Proposed Clinical Trial of HBOC-201 in Trauma (pdf)

Special Government Employee Reviews: Cover Note (htm)

Review 1: IND 12504:HBOC-210 (Polymerized Bovine Hemoglobin-B): Request for consultative review of efficacy of HBOC-210 vs. lactated Ringer's solution in a porcine hypopvolemic shock model (pdf)

Review 2: Executive summary BPAC Meeting on RESUS, Use of HBOC-201 (pdf)

Review 3: Summary of a review of preclinical studies of the use of HBOC-201 in the treatment of hemorrhagic shock (pdf)

Review 4: RESUS Trial, Lawrence Landau, M.D. (pdf)

Review 5: BB-IND 12504:HBOC-201 (Polymerized Bovine Hemoglobin-B): Amendment SN0006 (pdf)

Review 6: Response to the proposed Phase III trials by the Navy Medical Research Center on Biologic agent HBOC-201 (pdf)

Review 7: Default infusion rate (pdf)

Review 8: Executive Summary (pdf)

Sponsor

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.

Naval Medical Research Center (pdf)