LEADER 08066nam 2200685 a 450 001 9910970045603321 005 20251017110156.0 010 $a9786610246861 010 $a9781280246869 010 $a1280246863 010 $a9780309585200 010 $a0309585201 010 $a9780585085500 010 $a0585085501 035 $a(CKB)110986584751250 035 $a(SSID)ssj0000156460 035 $a(PQKBManifestationID)11160004 035 $a(PQKBTitleCode)TC0000156460 035 $a(PQKBWorkID)10129452 035 $a(PQKB)11247446 035 $a(MiAaPQ)EBC3376294 035 $a(Au-PeEL)EBL3376294 035 $a(CaPaEBR)ebr10055382 035 $a(CaONFJC)MIL24686 035 $a(OCoLC)923262665 035 $a(Perlego)4735727 035 $a(DNLM)744063 035 $a(EXLCZ)99110986584751250 100 $a19930311d1992 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aFood and Drug Administration advisory committees /$fCommittee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1992 215 $axii, 226 p. $cill 300 $a"Division of Health Care [sic] Policy, Institute of Medicine." 311 08$a9780309048378 311 08$a0309048370 320 $aIncludes bibliographical references. 327 $aFood 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. 327 $aTHE 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. 327 $aDermatologic 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. 327 $aTYPES 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. 606 $aPublic health advisory groups$zUnited States$xEvaluation 615 0$aPublic health advisory groups$xEvaluation. 676 $a353.0077/8 701 $aRettig$b Richard A$01803761 701 $aEarley$b Laurence E$01803762 701 $aMerrill$b Richard A$0100299 712 02$aInstitute of Medicine (U.S.).$bDivision of Health Sciences Policy. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910970045603321 996 $aFood and Drug Administration advisory committees$94351443 997 $aUNINA