Blood banking and regulation : procedures, problems, and alternatives / Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor
FDA policy and regulation / Michael Beatrice -- CDC recommendations / Lyle Petersen -- Blood banking's policy groups and procedures / Toby Simon -- Opportunities and venues for dialogue / Merlyn Sayers -- CBER compliance activity / James Simmons -- FDA practice in the field / Richard Swanson -- Challenges and questions about compliance / William Sherwood -- Regulatory alternatives / Sidney Shapiro -- Specific techniques / David Pritzker -- Negotiated rule-making / Philip Harter -- Panel discussion on applications of negotiated rule-making to issues in blood banking / Kathryn C. Zoon, Jay Epstein, Toby Simon -- Congressional oversight of blood safety issues / Anne Marie Finley -- DHHS Task Force on HIV and the blood supply / Mary Pendergast -- Investing in regulatory quality / Edward A. Dauer
Notes
"The talks summarized in this document were originally given at workshops on Alter[n]ative Regulatory Models (January, 1995); CBER Compliance Acivity, Theory and Practice (September, 1995); and Managing Threats to the Blood Supply (September, 1995)"--Page vii
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