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False hope [[electronic resource] ] : bone marrow transplantation for breast cancer / / Richard A. Rettig ... [et al.]
| False hope [[electronic resource] ] : bone marrow transplantation for breast cancer / / Richard A. Rettig ... [et al.] |
| Pubbl/distr/stampa | Oxford ; ; New York, : Oxford University Press, 2007 |
| Descrizione fisica | 1 online resource (368 p.) |
| Disciplina | 616.99/449061 |
| Altri autori (Persone) | RettigRichard A |
| Soggetto topico |
Breast - Cancer - Chemotherapy - United States - History
Bone marrow - Transplantation - United States - History Autotransplantation - United States - History Breast - Cancer - Chemotherapy - Complications Bone marrow - Transplantation - Complications Autotransplantation - Complications |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-84585-6
9786610845859 0-19-974824-1 1-4294-5923-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Breast cancer patients and the emergence of a treatment -- Jumping the gun -- Court trials -- Litigation strategies -- Entrepreneurial oncology -- Government mandates -- Technology assessments -- Clinical trials -- Dénouement -- Values in conflict. |
| Record Nr. | UNINA-9910451472603321 |
| Oxford ; ; New York, : Oxford University Press, 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
False hope [[electronic resource] ] : bone marrow transplantation for breast cancer / / Richard A. Rettig ... [et al.]
| False hope [[electronic resource] ] : bone marrow transplantation for breast cancer / / Richard A. Rettig ... [et al.] |
| Pubbl/distr/stampa | Oxford ; ; New York, : Oxford University Press, 2007 |
| Descrizione fisica | 1 online resource (368 p.) |
| Disciplina | 616.99/449061 |
| Altri autori (Persone) | RettigRichard A |
| Soggetto topico |
Breast - Cancer - Chemotherapy - United States - History
Bone marrow - Transplantation - United States - History Autotransplantation - United States - History Breast - Cancer - Chemotherapy - Complications Bone marrow - Transplantation - Complications Autotransplantation - Complications |
| ISBN |
0-19-770665-7
1-280-84585-6 9786610845859 0-19-974824-1 1-4294-5923-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Breast cancer patients and the emergence of a treatment -- Jumping the gun -- Court trials -- Litigation strategies -- Entrepreneurial oncology -- Government mandates -- Technology assessments -- Clinical trials -- Dénouement -- Values in conflict. |
| Record Nr. | UNINA-9910777874403321 |
| Oxford ; ; New York, : Oxford University Press, 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
False hope : bone marrow transplantation for breast cancer / / Richard A. Rettig ... [et al.]
| False hope : bone marrow transplantation for breast cancer / / Richard A. Rettig ... [et al.] |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Oxford ; ; New York, : Oxford University Press, 2007 |
| Descrizione fisica | 1 online resource (368 p.) |
| Disciplina | 616.99/449061 |
| Altri autori (Persone) | RettigRichard A |
| Collana | Oxford scholarship online |
| Soggetto topico |
Breast - Cancer - Chemotherapy - United States - History
Bone marrow - Transplantation - United States - History Autotransplantation - United States - History Breast - Cancer - Chemotherapy - Complications Bone marrow - Transplantation - Complications Autotransplantation - Complications |
| ISBN |
0-19-770665-7
1-280-84585-6 9786610845859 0-19-974824-1 1-4294-5923-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Breast cancer patients and the emergence of a treatment -- Jumping the gun -- Court trials -- Litigation strategies -- Entrepreneurial oncology -- Government mandates -- Technology assessments -- Clinical trials -- Denouement -- Values in conflict. |
| Record Nr. | UNINA-9910810897503321 |
| Oxford ; ; New York, : Oxford University Press, 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Federal regulation of methadone treatment [[electronic resource] /] / Richard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine
| Federal regulation of methadone treatment [[electronic resource] /] / Richard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1995 |
| Descrizione fisica | 1 online resource (250 p.) |
| Disciplina | 353.0084/29 |
| Altri autori (Persone) |
RettigRichard A
YarmolinskyAdam |
| Soggetto topico |
Methadone maintenance - Government policy - United States
Drug monitoring - Government policy - United States Methadone hydrochloride |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-19303-4
9786610193035 0-309-59862-1 0-585-15457-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456010603321 |
| Washington, D.C., : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Federal regulation of methadone treatment [[electronic resource] /] / Richard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine
| Federal regulation of methadone treatment [[electronic resource] /] / Richard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1995 |
| Descrizione fisica | 1 online resource (250 p.) |
| Disciplina | 353.0084/29 |
| Altri autori (Persone) |
RettigRichard A
YarmolinskyAdam |
| Soggetto topico |
Methadone maintenance - Government policy - United States
Drug monitoring - Government policy - United States Methadone hydrochloride |
| ISBN |
0-309-17658-1
1-280-19303-4 9786610193035 0-309-59862-1 0-585-15457-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778654203321 |
| Washington, D.C., : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Federal regulation of methadone treatment / / Richard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine
| Federal regulation of methadone treatment / / Richard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1995 |
| Descrizione fisica | 1 online resource (250 p.) |
| Disciplina | 353.0084/29 |
| Altri autori (Persone) |
RettigRichard A
YarmolinskyAdam |
| Soggetto topico |
Methadone maintenance - Government policy - United States
Drug monitoring - Government policy - United States Methadone hydrochloride |
| ISBN |
0-309-17658-1
1-280-19303-4 9786610193035 0-309-59862-1 0-585-15457-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Federal Regulation of Methadone Treatment -- Copyright -- Acknowledgments -- Contents -- Federal Regulation of Methadone Treatment -- Executive Summary -- HOW METHADONE IS REGULATED -- SCOPE OF THE REPORT -- BALANCING THE BENEFITS AND RISKS OF METHADONE -- RECOMMENDATIONS TO MODIFY AND SUPPLEMENT THE REGULATIONS -- Diagnosing Addiction and Determining Dose Levels -- Habilitative and Rehabilitative Services -- Treating Pregnant Opiate Addicts -- Replacing "Detoxification" with "Medically Supervised Withdrawal -- Inpatient Hospital Admissions -- Treating Opiate Addiction and Treating Pain -- ENFORCEMENT OF THE REGULATIONS -- GUIDELINES AND QUALITY ASSURANCE -- PROCESS EVALUATION AND OUTCOME EVALUATION -- FEDERAL GOVERNMENT LEADERSHIP -- REFERENCE -- 1 Introduction -- THE CHARGE TO THE COMMITTEE -- OBJECTIVES OF OPIATE ADDICTION TREATMENT -- EFFECTIVENESS OF METHADONE MAINTENANCE TREATMENT -- Beneficial Outcomes -- Factors Limiting Effectiveness -- Multiple Problems of Methadone Maintenance Patients -- Variability among Methadone Maintenance Programs -- WHY METHADONE IS REGULATED DIFFERENTLY FROM OTHER DRUGS -- THE COMMITTEE'S VIEW -- REPORT ORGANIZATION -- STUDY METHODS -- A NOTE ON TERMINOLOGY -- REFERENCES -- 2 Pharmacology and Medical Aspects of Methadone Treatment -- THE RATIONALE FOR PHARMACOTHERAPY -- History and Practice -- Basic Science -- PHARMACOKINETICS OF METHADONE -- METHADONE MAINTENANCE -- Treatment Regimen -- Effects, Side Effects, and Special Pharmacological Issues -- Physiological Functions Disrupted During Heroin Addiction -- INTERACTIONS OF METHADONE WITH OTHER DRUGS -- IMPACT OF METHADONE MAINTENANCE ON INFECTIOUS DISEASES -- REFERENCES -- 3 Who are the Recipients of Treatment? -- HEROIN USE AND DEPENDENCE -- Prevalence of Heroin Use -- From Use to Dependence -- How Persistent is Heroin Dependence?.
Age, Gender, and Ethnicity -- Age -- Gender -- Ethnicity -- What Other Substances Do Heroin Users Consume? -- Other Medical and Social Problems of Heroin-Dependent Persons -- How Likely Are Heroin Addicts to Use Treatment? -- CHARACTERISTICS OF UNTREATED AND TREATED HEROIN ADDICTS -- METHADONE PATIENT CHARACTERISTICS -- Historical Trends -- Current Patient Characteristics -- Methadone in Drug Treatment: General -- Use of Methadone in Detoxification -- Use of Methadone in Maintenance Treatment -- Contrast between Detoxification and Maintenance Patient Admissions -- Maintenance Patients in New York State -- 1992 -- Maintenance Patients in California, 1992 -- Differences Between New York and California -- SUMMARY -- REFERENCES -- 4 Methadone Diversion Control -- EARLY CONCERN OVER DIVERSION -- THE NARCOTIC ADDICT TREATMENT ACT OF 1974 -- MORE RECENT OFFICIAL VIEWS ON DIVERSION -- House Select Committee Hearings -- Perspective of the Drug Enforcement Administration -- THE DATA ON DIVERSION -- Drug Abuse Warning Network Data -- Harris County, Texas -- Harris County Medical Examiner Data -- Methadone Maintenance Treatment Data -- Independent Pathologists' Review -- Drug Abuse Warning Network (DAWN) Medical Examiner Data -- Other Data on Diversion -- Drug Use Forecasting Data -- National AIDS Demonstration Research (NADR) Data -- HOW IS METHADONE DIVERTED? -- Production and Distribution System -- Sale by Patients: Who Sells and Why? -- WHO USES DIVERTED METHADONE AND WHY? -- CONSEQUENCES OF METHADONE DIVERSION -- Public Safety Issues -- Public Health Issues -- Is Diverted Methadone Dangerous? -- Is Diverted Methadone a Major Drug of Abuse? -- SUMMARY -- APPENDIX -- REFERENCES -- 5 Federal Regulation of Methadone Treatment -- THE 1960S -- THE NIXON ADMINISTRATION -- 1970 Legislation -- Special Action Office for Drug Abuse Presentation. DEFINING THE REGULATORY REGIME: 1970-1974 -- Research, Treatment, and Regulation -- Methadone IND Regulations -- 1972 Regulations -- Legal Challenge to the FDA -- Narcotic Addict Treatment Act of 1974 -- Summary: 1970-1974 -- THE CURRENT REGULATORY REGIME -- 1980 Revision of the Regulations -- 1989 Revision of the Regulations -- 1983 Regulatory Reform Initiative -- 1987 Notice of Proposed Rule-Making -- 1989 Final Rule -- 1989 Guidance Document -- 1989 Interim Methadone Maintenance Proposal -- Assessment of Program Performance -- LEVO-ALPHA-ACETYL-METHADOL -- SUMMARY -- REFERENCES -- 6 Methadone Treatment -- THE PROVIDER COMMUNITY -- Number of Treatment Facilities -- Regional Variation -- Number of Patients -- Capacity and Utilization Rate -- Waiting Lists -- Facility Ownership -- FINANCING OF METHADONE TREATMENT -- Department of Veterans Affairs -- Out-of-Pocket and Private Insurance -- STATE SUBSTANCE ABUSE AGENCIES -- New York -- Financing -- Regulations -- California -- Financing -- Regulations -- Florida -- Financing -- Regulations -- Illinois -- Financing -- Regulations -- Massachusetts -- Financing -- Regulations -- SUMMARY -- REFERENCES -- 7 Treatment Standards and Optimal Treatment -- DEFINITION OF TERMS -- PATIENT EVALUATION AND ADMISSION CRITERIA -- Admission to Medically Supervised Withdrawal -- Admission to Maintenance Pharmacotherapy -- Proper Patient Placement -- Two Conclusions -- MAINTENANCE PHARMACOTHERAPY -- Dosing -- Comprehensive Treatment Services -- Take-Home Medication -- Urine Testing -- Implications for Regulations -- Opiate Addiction in Pregnant Women -- MEDICALLY SUPERVISED WITHDRAWAL -- INPATIENT TREATMENT -- Maintenance Pharmacotherapy in Hospital Inpatient Settings -- Inpatients with Untreated Opiate Addiction -- PAIN MANAGEMENT -- Non-Opiate-Addicted Pain Patients -- Methadone Patients. ''Recovering" Opiate and Other Substance Dependent Patients -- CONCLUDING COMMENTS -- REFERENCES -- 8 Implementing Standards-and Beyond -- REGULATIONS AND THEIR ENFORCEMENT -- CLINICAL PRACTICE GUIDELINES -- FORMAL QUALITY ASSURANCE SYSTEMS -- WHAT CAN BE DONE NOW? -- Process Evaluation -- Outcome Evaluation -- FEDERAL GOVERNMENT LEADERSHIP -- Research Issues -- Clinical Research -- Health Services Research -- Federal-State Relations -- Financing of Treatment -- Policy Guidance -- SUMMARY -- REFERENCES. |
| Record Nr. | UNINA-9910817702903321 |
| Washington, D.C., : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors
| Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1992 |
| Descrizione fisica | xii, 226 p. : ill |
| Disciplina | 353.0077/8 |
| Altri autori (Persone) |
RettigRichard A
EarleyLaurence E MerrillRichard A |
| Soggetto topico | Public health advisory groups - United States - Evaluation |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-24686-3
9786610246861 0-309-58520-1 0-585-08550-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910455935203321 |
| Washington, D.C., : National Academy Press, 1992 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors
| Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1992 |
| Descrizione fisica | xii, 226 p. : ill |
| Disciplina | 353.0077/8 |
| Altri autori (Persone) |
RettigRichard A
EarleyLaurence E MerrillRichard A |
| Soggetto topico | Public health advisory groups - United States - Evaluation |
| ISBN |
1-280-24686-3
9786610246861 0-309-58520-1 0-585-08550-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778795803321 |
| Washington, D.C., : National Academy Press, 1992 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Food and Drug Administration advisory committees / / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors
| Food and Drug Administration advisory committees / / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1992 |
| Descrizione fisica | xii, 226 p. : ill |
| Disciplina | 353.0077/8 |
| Altri autori (Persone) |
RettigRichard A
EarleyLaurence E MerrillRichard A |
| Soggetto topico | Public health advisory groups - United States - Evaluation |
| ISBN |
1-280-24686-3
9786610246861 0-309-58520-1 0-585-08550-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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.
THE PRODUCT EVALUATION PROCESS -- The Drug Evaluation Process -- The Biologics Approval Process -- The Device Approval Process -- AGENCY WORKLOAD AND ADVISORY COMMITTEES -- OFFICIAL PURPOSES OF ADVISORY COMMITTEES -- The FDA Regulations -- The NDA Rewrite -- Medical Device Statutes -- FDA Advisory Committee Charters -- THE USES OF ADVISORY COMMITTEES -- Variations Among Centers -- Center Workload and Stage of Advisory Committee Use -- Other Means of Seeking Advice -- SUMMARY -- NOTES -- 4 Recurring Issues -- MAJOR PRIOR REPORTS -- The Fountain Committee Report (1976) -- The Dorsen Committee Report (1977) -- The McMahon Commission Report (1982) -- The Lasagna Committee Report (1990) -- Other Reports -- THE GOLDFISH BOWL -- Congressional Oversight -- Media Coverage -- The Financial Community -- CONCLUSIONS -- NOTES -- 5 Committee Membership -- NOMINATION CRITERIA -- General and Specific Criteria -- Diversity Objectives -- Balance -- Implications -- RECRUITMENT PROCEDURES -- CONSUMER MEMBERS -- APPOINTMENT AUTHORITY -- ADMINISTRATIVE RESPONSIBILITY FOR APPOINTMENTS -- 6 Ensuring Committee Integrity -- FINANCIAL CONFLICT OF INTEREST -- THE STATUTORY FRAMEWORK -- Subsection 208(b)(1) -- Subsection 208(b)(2) -- Subsection 208(b)(3) -- FDA'S ADMINISTRATION OF CONFLICT-OF-INTEREST RESTRICTIONS -- Screening Potential Committee Members -- Identification of Conflict and Decision to Seek a Waiver -- A RAPIDLY CHANGING SYSTEM -- Notable Controversies -- Psychopharmaceutical Drugs Advisory Committee: Meeting of September20, 1991 -- General and Plastic Surgery Devices Advisory Panel: Meeting of November12-13, 1991 -- Arthritis Drugs Advisory Committee: Meeting of December 6, 1991 -- Blood Products Advisory Committee Meeting: December 12-13, 1991 -- Biologics Response Modifiers Advisory Committee: Meeting of January 16-17, 1992. Dermatologic Drugs Advisory Committee: Meeting of April 10, 1992 -- Circulatory Systems Devices Panel: Meeting of May 11, 1992 -- Analysis of Waiver Processing -- Interpretation -- Glimmers of Progress -- Workload -- Waiver Preparation and Review -- Schedule for Review of Waivers -- Waiver Form -- RECOMMENDATIONS ON FINANCIAL CONFLICT OF INTEREST -- Options Requiring Legislation -- Options Available Within Existing Authority -- INTELLECTUAL BIAS -- Remedies -- Screening -- NOTES -- APPENDIX -- A Suggested Approach to the Codification of Section 208(b)(3) Waiver Criteria -- 7 Committee Operations -- SCHEDULING ADVISORY COMMITTEE MEETINGS -- MEETING PREPARATION -- General Criteria for Setting the Agenda -- Product Evaluation and Guidelines Development at CDER -- Program Management at CDER -- Setting the Agenda -- Content of the Agenda Questions -- Timely Distribution of Materials -- Summaries of Materials Sent to the Committee -- Use of Primary Reviewers -- Communications Issues Before an Advisory Committee Meeting -- FDA Communication to Advisory Committee Members -- Communication Among Advisory Committee Members -- Communication Between Sponsors and Advisory Committee Members -- Agency Communication to Sponsors -- Communication Between the FDA and the Public -- CONDUCTING AN ADVISORY COMMITTEE MEETING -- Roles of the Principal Participants -- Allocation and Control of Agenda Time -- Electronic Coverage of Meetings -- Voting -- Agency Neutrality -- Agency Presentations -- FDA-Committee Interaction -- Seating Arrangements -- Closed Deliberations -- CUSTOM TAILORING OF COMMITTEE MEMBERSHIP -- MEETING FOLLOW-UP -- NOTES -- 8 Organization and Management -- SYSTEM MANAGEMENT -- The Commissioner and His Office -- Center Directors -- Office and Division Directors -- Executive Secretaries -- COMPENSATION -- ORIENTATION AND TRAINING. TYPES OF ADVISORY COMMITTEES -- Policy Advisory Committee -- Other Issues -- AGENCY MANAGEMENT AND ACCOUNTABILITY -- Agency Management -- Agency Accountability -- A CONCLUDING RECOMMENDATION -- NOTES -- Appendix A Resource Implications -- CURRENT SYSTEM COSTS UNDERESTIMATED -- RECOMMENDATIONS THAT WILL HAVE RESOURCE IMPLICATIONS -- Appendix B Glossary. |
| Record Nr. | UNINA-9910827560703321 |
| Washington, D.C., : National Academy Press, 1992 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Kidney failure and the federal government [[electronic resource] /] / Committee for the Study of the Medicare End-Stage Renal Disease Program, Division of Health Care Services, Institute of Medicine ; Richard A. Rettig and Norman G. Levinsky, editors
| Kidney failure and the federal government [[electronic resource] /] / Committee for the Study of the Medicare End-Stage Renal Disease Program, Division of Health Care Services, Institute of Medicine ; Richard A. Rettig and Norman G. Levinsky, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1991 |
| Descrizione fisica | xiv, 426 p. : ill |
| Disciplina | 362.1/9614/00973 |
| Altri autori (Persone) |
RettigRichard A
LevinskyNorman G <1929-> (Norman George) |
| Soggetto topico |
Chronic renal failure - Government policy - United States
Medicare |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-20398-6
9786610203987 0-309-59769-2 0-585-15560-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910455132203321 |
| Washington, D.C., : National Academy Press, 1991 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
