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

• Pubblicazione: Washington, D.C., : National Academy Press, 1992
• Edizione: 1st ed.
• Descrizione fisica: xii, 226 p. : ill
• Disciplina: 353.0077/8
• Soggetto topico: Public health advisory groups - United States - Evaluation
• Altri autori: RettigRichard A EarleyLaurence E MerrillRichard A
• Note generali: "Division of Health Care [sic] Policy, Institute of Medicine."
• Nota di bibliografia: Includes bibliographical references.
• 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.
• Sommario/riassunto: Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
• Titolo autorizzato: Food and Drug Administration advisory committees
• ISBN: 9786610246861; 9781280246869; 1280246863; 9780309585200; 0309585201; 9780585085500; 0585085501
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910970045603321
• Lo trovi qui: Univ. Federico II