00965nam a22002531i 450099100270004970753620030909132006.0030925s1909 it |||||||||||||||||ita b12326355-39ule_instARCHE-037389ExLBiblioteca InterfacoltàitaA.t.i. Arché s.c.r.l. Pandora Sicilia s.r.l.920.045Roux, Onorato454328Artisti /per cura di Onorato RouxFirenze :Bemporad e Figlio,1909v. ;19 cmInfanzia e giovinezza di illustri italiani contemporanei ;2Uomini celebri italianiSec. 19..b1232635502-04-1408-10-03991002700049707536LE002 It. XI N 5a (Fondo Sanesi)V. 2.212002000170040le002-E0.00-no 00000.i1272563808-10-03Artisti161114UNISALENTOle00208-10-03ma -itait 0108066nam 2200685 a 450 991097004560332120251017110156.09786610246861978128024686912802468639780309585200030958520197805850855000585085501(CKB)110986584751250(SSID)ssj0000156460(PQKBManifestationID)11160004(PQKBTitleCode)TC0000156460(PQKBWorkID)10129452(PQKB)11247446(MiAaPQ)EBC3376294(Au-PeEL)EBL3376294(CaPaEBR)ebr10055382(CaONFJC)MIL24686(OCoLC)923262665(Perlego)4735727(DNLM)744063(EXLCZ)9911098658475125019930311d1992 uy 0engurcn|||||||||txtccrFood 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, editors1st ed.Washington, D.C. National Academy Press1992xii, 226 p. ill"Division of Health Care [sic] Policy, Institute of Medicine."9780309048378 0309048370 Includes bibliographical references.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.Public health advisory groupsUnited StatesEvaluationPublic health advisory groupsEvaluation.353.0077/8Rettig Richard A1803761Earley Laurence E1803762Merrill Richard A100299Institute of Medicine (U.S.).Division of Health Sciences Policy.MiAaPQMiAaPQMiAaPQBOOK9910970045603321Food and Drug Administration advisory committees4351443UNINA