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1Publicado 2003Materias: “…Estados Unidos Food and Drug Administration Historia…”
Libro -
2Publicado 1998“…Food and Drug Administration Bacteriological analytical manual…”
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3por Institute of Medicine (U.S.).Tabla de Contenidos: “…Food and Drug Administration Advisory Committees -- Copyright -- Preface -- NOTES -- Acknowledgments -- Contents -- List of Abbreviations -- Summary -- The Roles of FDA Advisory Committees -- Practical Limits on Advisory Committees -- COMMITTEE MEMBERSHIP -- Nomination Criteria -- Recruitment Procedures -- Consumer Members -- Appointment Authority -- Administrative Responsibility for Appointments -- COMMITTEE INTEGRITY -- Options Requiring Legislation -- Options Available within Existing Authority -- COMMITTEE OPERATIONS -- Scheduling Meetings -- Meeting Preparation -- General Criteria for Setting the Agenda -- Setting Specific Agendas -- Timely Distribution of Materials -- Summaries of Materials Sent to Advisory Committees -- Use of Primary Reviewers -- Communications Issues -- Conducting an Advisory Committee Meeting -- Allocation and Control of Agenda Time -- Electronic Coverage of Meetings -- Voting -- Agency Neutrality -- Custom Tailoring of Committee Membership -- Meeting Follow-up -- ORGANIZATION AND MANAGEMENT -- System Management -- Compensation -- Orientation and Training -- AGENCY MANAGEMENT AND ACCOUNTABILITY -- Agency Management -- Agency Accountability -- A CONCLUDING RECOMMENDATION -- NOTES -- 1 Introduction -- ORIGINS OF THE STUDY -- STUDY OBJECTIVES -- SCOPE OF THE STUDY -- THE ROLES OF FDA ADVISORY COMMITTEES -- PRACTICAL LIMITS ON THE USE OF ADVISORY COMMITTEES -- THE FEDERAL ADVISORY COMMITTEE ACT -- STUDY METHODS -- REPORT ORGANIZATION -- A NOTE ON CROSS-NATINOAL COMPARISONS -- APPENDIX -- NOTE -- 2 Historical Evolution of FDA Advisory Committees -- DRUGS -- Drug Efficacy Study -- Over-the-Counter Drugs -- Prescription Drug Review -- Summary -- BIOLOGICS -- MEDICAL DEVICES -- The Cooper Report -- The Medical Device Amendments of 1976 -- NIH STUDY SECTIONS -- SUMMARY -- NOTES -- 3 The FDA Advisory Committee System…”
Publicado 1992
Libro electrónico -
4Publicado 2011Tabla de Contenidos: “…""Front Matter""; ""Preface""; ""Contents""; ""A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration""; ""Summary""; ""1 Introduction""; ""2 A Risk-Characterization Framework""; ""3 Case Study of a Mitigation-Selection Decision""; ""4 Case Study of a Targeting Decision""; ""5 Case Study of a Strategic-Investment Decision""; ""6 Case Study of a Targeting Decision That Spans Food and Drug Administration Centers""; ""7 Conclusions and Future Directions""…”
Libro electrónico -
5por Institute of Medicine (U.S.).Tabla de Contenidos: “…Food and Drug Administration's Food Defense Program""; ""Appendix E: The U.S. …”
Publicado 2010
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10Publicado 1999Materias: “…United States. Food and Drug Administration…”
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13por Strengthening a Workforce for Innovative Regulatory Science in Therapeutics DevelopmentMaterias: “…United States. Food and Drug Administration Personnel management Congresses…”
Publicado 2012
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15Publicado 2008Materias: “…Estados Unidos Food and Drug Administration…”
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16Publicado 1995Materias: “…United States. Food and Drug Administration Periodicals…”
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18Publicado 2016Materias: “…United States. Food and Drug Administration…”
Libro electrónico -
19Publicado 2017Materias: “…United States. Food and Drug Administration…”
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20por Institute of Medicine (U.S.).Materias: “…United States. Food and Drug Administration…”
Publicado 2010
Libro electrónico