Food and Drug Administration Advisory Committees.
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| Format: | Electronic eBook |
| Language: | English |
| Published: |
Washington :
National Academies Press,
1900
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| Subjects: | |
| Local Note: | ProQuest Ebook Central |
Table of Contents:
- ""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""
