Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Kennedy spotlights West Nile virus: Pathogen inactivation technology deemed "promising" in written remarks from Sen. Edward Kennedy (D-Mass.) to FDA commissioner-nominee Mark McClellan, MD/PhD. "Should it be a priority for FDA to evaluate this exciting new technology?" Kennedy asks. "Pathogen inactivation may prove valuable as an approach to reducing risk in blood products," McClellan replies. "These approaches, however, must be carefully evaluated for their immediate and long-term safety," he cautions...
You may also be interested in...
CBER Reorganization Poses “Significant” Staff Retention Issues – Zoon
The reorganization of FDA's Center for Biologics Evaluation & Research poses a significant problem for employee retention, Director Kathryn Zoon told the FDA Science Board Oct. 25
CBER Reorganization Poses “Significant” Staff Retention Issues – Zoon
The reorganization of FDA's Center for Biologics Evaluation & Research poses a significant problem for employee retention, Director Kathryn Zoon told the FDA Science Board Oct. 25
West Nile Virus Nucleic Acid Firms Will Hear Regulatory Guidance Nov. 4-5
Blood banks expect to begin screening donated blood for the West Nile Virus using nucleic acid tests (NAT) by mid-2003 under an IND exemption