| Description |
1 online resource (140 pages) |
| Contents |
""Blood Banking and Regulation: Procedures, Problems, and Alternatives""; ""Copyright""; ""Foreword""; ""Preface""; ""Contents""; ""I Overview of Regulatory and Policy-Making Procedures in Blood Banking""; ""FDA Policy and Regulation""; ""THE REGULATORY MANDATE""; ""REGULATORY MECHANISMS""; ""LEGAL AUTHORITIES""; ""REGULATION AND ENFORCEMENT AT FDA""; ""ENSURING BLOOD SAFETY AND AVAILABILITY IN THE FUTURE""; ""CDC Recommendations""; ""CDC'S MISSION""; ""EFFECTIVENESS OF CDC""; ""RESEARCH ON HIV""; ""HOW CDC AFFECTS POLICY""; ""FORMAL RECOMMENDATIONS"" |
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""Blood Banking's Policy Groups and Procedures""""THE TRADITION OF SELF-REGULATION""; ""STANDARD-SETTING ORGANIZATIONS""; ""AMERICAN ASSOCIATION OF BLOOD BANKS""; ""JOINT EFFORTS""; ""OTHER STANDARDS AND GUIDELINES""; ""Opportunities and Venues for Dialogue""; ""THE CHANGING CLIMATE IN BLOOD BANKING""; ""VENUES FOR DIALOGUE""; ""THE BLOOD PRODUCTS ADVISORY COMMITTEE""; ""OTHER VENUES FOR DIALOGUE""; ""THE VOICE OF BLOOD PRODUCT CONSUMERS""; ""ATTENDING TO THE DONOR""; ""REGULATORY DIFFICULTIES""; ""Discussion""; ""II Regulatory Enforcement And Compliance""; ""CBER Compliance Activity"" |
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""COORDINATION BETWEEN THE CENTERS AND THE FIELD""""OFFICE OF REGULATORY AFFAIRS""; ""INSPECTION CONSISTENCY""; ""INSPECTIONS AND ENFORCEMENT""; ""FDA Practice in the Field""; ""TRAINING FOR THE FIELD""; ""SOURCES OF CONSISTENCY""; ""Challenges and Questions About Compliance""; ""IMPROVEMENTS IN SAFETY""; ""QUESTIONS ABOUT ENFORCEMENT""; ""Evidence That Compliance Works""; ""Indirect Effects: ""Bulletproofing""""; ""Is Compliance Improving?""; ""REGULATION AND OTHER FORCES""; ""Discussion""; ""III Innovations and Alternatives in Regulation""; ""Regulatory Alternatives"" |
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""REGULATORY DIAGNOSIS AND MISMATCH""""MAXIMIZING EFFECTIVENESS AND EFFICIENCY""; ""PROPOSED ALTERNATIVES TO COMMAND-AND-CONTROL""; ""Specific Techniques""; ""ACUS STUDY AND RECOMMENDATIONS""; ""THE ADMINISTRATIVE PROCEDURE ACT""; ""THE ALTERNATIVE: NEGOTIATION""; ""RECENT DEVELOPMENTS AND THE FEDERAL ADVISORY COMMITTEE ACT (FACA)""; ""AUDITED SELF-REGULATION""; ""Negotiated Rule-Making""; """"REG-NEG""�DOES IT WORK?""; ""THE PUBLIC AT THE NEGOTIATION TABLE""; ""CONSENSUS""; ""DECISION-MAKING DYNAMICS""; ""BENEFITS OF COLLABORATION""; ""POLITICAL CONSENSUS""; ""REG-NEG OUTCOMES"" |
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""GETTING REG-NEG STARTED""""CHOOSING THE PROBLEM""; ""OTHER REQUISITES""; ""CONSTITUENCY PRESSURES""; ""ACCOUNTABILITY""; ""REG-NEG PROCESS""; ""QUESTIONS ABOUT REG-NEG""; ""Panel Discussion on Applications of Negotiated Rule-Making to Issues in Blood Banking""; ""Kathryn C. Zoon""; ""REGULATORY INITIATIVES AT FDA""; ""FDA IN THE FUTURE""; ""INITIATIVES AT CBER""; ""WILLINGNESS TO EXPLORE PILOTS""; ""Jay Epstein""; ""INITIATIVES IN BLOOD REGULATION""; ""PARTICIPATORY DECISION-MAKING""; ""PUBLIC MEETINGS""; ""NATIONAL PERFORMANCE REVIEW""; ""EXPERIMENTS IN REGULATION"" |
| Notes |
""The forces of change"" |
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Print version record |
| Subject |
Blood banks -- Safety regulations -- United States
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Blood -- Transfusion -- Safety regulations -- United States
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Blood banks -- Safety regulations
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United States
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| Form |
Electronic book
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| Author |
Dauer, Edward A
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| ISBN |
9780309589505 |
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0309589509 |
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