Hemopure advisory committee
Executive Summary
FDA's Blood Products Advisory Committee will meet Dec. 14 to review Biopure's experimental blood product Hemopure [hemoglobin glutamer-250(bovine)] for out-of-hospital treatment of hermorrhagic shock, including the Navy's proposed RESUS clinical trial of the oxygen therapeutic. A closed-door meeting of the panel to discuss Hemopure was scheduled last July but was cancelled due to concerns about the need for more public input (1"The Pink Sheet" Sept. 11, 2006, p. 24). The meeting will be held from 8 a.m. to 6 p.m. at the Crown Plaza in Silver Spring, MD...
You may also be interested in...
FDA May Use Panels More Often To Evaluate Emergency Research Protocols
FDA is questioning whether protocols for emergency research conducted without individual informed consent should be subjected to more public input
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.