{"text_format":"2","workbook":"xls","n_sheets":1,"sheets":["report2"],"not_rendered":{"charts":0,"images":0,"macros":0,"external_links":1,"defined_names":1,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"run_cost":"one","rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"report2","index":0,"n_rows":25,"n_cols":5,"rows_kept":25,"cut":false,"hidden":false,"merged":[[0,2,0,3],[0,4,0,5],[1,2,1,3],[1,4,1,5],[2,2,2,3],[3,2,3,3],[10,2,10,3],[11,2,11,3],[12,2,12,3],[13,2,13,3],[14,2,14,3],[15,2,15,3],[19,2,19,3]],"flags":["formulas_cached_only"]}
[null,"1.","Record Nr.",null,"UNINA9910970045603321"]
[null,null,"Titolo",null,"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"]
[null,null,"Pubbl/distr/stampa",null,"Washington, D.C., : National Academy Press, 1992"]
[null,null,"ISBN",null,"9786610246861"]
[{"$nulls":4},"9781280246869"]
[{"$nulls":4},"1280246863"]
[{"$nulls":4},"9780309585200"]
[{"$nulls":4},"0309585201"]
[{"$nulls":4},"9780585085500"]
[{"$nulls":4},"0585085501"]
[null,null,"Edizione",null,"[1st ed.]"]
[null,null,"Descrizione fisica",null,"xii, 226 p. : ill"]
[null,null,"Disciplina",null,"353.0077/8"]
[null,null,"Soggetti",null,"Public health advisory groups - United States - Evaluation"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","\"Division of Health Care [sic] Policy, Institute of Medicine.\""]
[null,null,null,"Nota di bibliografia","Includes bibliographical references."]
[null,null,"Nota di contenuto",null,"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 -- "]
[{"$nulls":4},"Agency Management -- Agency Accountability -- A CONCLUDING RECOMMENDATION -- NOTES -- 1 Introduction -- ORIGINS OF THE STUDY -- STUDY OBJECTIVES -- SCOPE OF THE STUDY -- THE ROLES OF FDA ADVISORY COMMITTEES -- PRACTICAL LIMITS ON THE USE OF ADVISORY COMMITTEES -- THE FEDERAL ADVISORY COMMITTEE ACT -- STUDY METHODS -- REPORT ORGANIZATION -- A NOTE ON CROSS-NATINOAL COMPARISONS -- APPENDIX -- NOTE -- 2 Historical Evolution of FDA Advisory Committees -- DRUGS -- Drug Efficacy Study -- Over-the-Counter Drugs -- Prescription Drug Review -- Summary -- BIOLOGICS -- MEDICAL DEVICES -- The Cooper Report -- The Medical Device Amendments of 1976 -- NIH STUDY SECTIONS -- SUMMARY -- NOTES -- 3 The FDA Advisory Committee System."]
[{"$nulls":4},"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."]
[{"$nulls":4},"Dermatologic Drugs Advisory Committee: Meeting of April 10, 1992 -- Circulatory Systems Devices Panel: Meeting of May 11, 1992 -- Analysis of Waiver Processing -- Interpretation -- Glimmers of Progress -- Workload -- Waiver Preparation and Review -- Schedule for Review of Waivers -- Waiver Form -- RECOMMENDATIONS ON FINANCIAL CONFLICT OF INTEREST -- Options Requiring Legislation -- Options Available Within Existing Authority -- INTELLECTUAL BIAS -- Remedies -- Screening -- NOTES -- APPENDIX -- A Suggested Approach to the Codification of Section 208(b)(3) Waiver Criteria -- 7 Committee Operations -- SCHEDULING ADVISORY COMMITTEE MEETINGS -- MEETING PREPARATION -- General Criteria for Setting the Agenda -- Product Evaluation and Guidelines Development at CDER -- Program Management at CDER -- Setting the Agenda -- Content of the Agenda Questions -- Timely Distribution of Materials -- Summaries of Materials Sent to the Committee -- Use of Primary Reviewers -- Communications Issues Before an Advisory Committee Meeting -- FDA "]
[{"$nulls":4},"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."]
[{"$nulls":4},"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."]