Blood banking and regulation procedures, problems, and alternatives (National Academy Press, 1996)
"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. - Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002
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