Tabla de Contenidos:
  • 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.