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Title 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.
Imprint Washington, D.C. : National Academy Press, ©1996.

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Subject Blood banks -- Safety regulations -- United States.
Blood -- Transfusion -- Safety regulations -- United States.
United States Food and Drug Administration.
Blood Banks -- United States -- legislation.
Blood Banks -- Congresses.
Blood Transfusion -- United States -- legislation.
Blood Transfusion -- Congresses.
Safety Management -- Congresses.
Alt Name Dauer, Edward A.
Forum on Blood Safety and Blood Availability.
Description 1 online resource (xii, 125 pages)
Note "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.
Contents 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.
Note Print version record.
Access Use copy Restrictions unspecified star
Reproduction Electronic reproduction. [S.l.] : HathiTrust Digital Library, 2010.
System Details 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.
Note digitized 2010 HathiTrust Digital Library committed to preserve pda
ISBN 0585155496 (electronic bk.)
9780585155494 (electronic bk.)
0309055466 (pbk.)
9780309055468 (pbk.)
9780309589505 (e-book)
OCLC # 43477314
Additional Format Print version: Blood banking and regulation. Washington, D.C. : National Academy Press, ©1996 0309055466 (DLC) 96069310 (OCoLC)35170692
Table of Contents
IOverview of Regulatory and Policy-Making Procedures in Blood Banking1
  FDA Policy and Regulation / Michael Beatrice3
  CDC Recommendations / Lyle Petersen9
  Blood Banking's Policy Groups and Procedures / Toby Simon13
  Opportunities and Venues for Dialogue / Merlyn Sayers19
IIRegulatory Enforcement and Compliance27
  CBER Compliance Activity / James Simmons29
  FDA Practice in the Field / Richard Swanson33
  Challenges and Questions About Compliance / William Sherwood35
IIIInnovations and Alternatives in Regulation47
  Regulatory Alternatives / Sidney Shapiro49
  Specific Techniques / David Pritzker55
  Negotiated Rule-Making / Philip Harter61
  Panel Discussion on Applications of Negotiated Rule-Making to Issues in Blood Banking / Kathryn C. Zoon, Jay Epstein, Toby Simon73
  General Discussion of Issues for Negotiated Rule-Making87
IVCongressional Oversight and Regulatory Initiatives91
  Congressional Oversight of Blood Safety Issues / Anne Marie Finley93
  DHHS Task Force on HIV and the Blood Supply / Mary Pendergast99
  Investing in Regulatory Quality / Edward A. Dauer105
ANegotiated Rule-Making Procedure109
BWorkshop Participants121

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