Food and Drug Administration advisory committees

Food and Drug Administration advisory committees

Bibliographic Details
Main Author: Institute of Medicine (U.S.).
Corporate Authors: Institute of Medicine (U.S.). Committee to Study the Use of Advisory Committees by the Food and Drug Administration (-), Institute of Medicine (U.S.). Division of Health Sciences Policy
Other Authors: Rettig, Richard A. (-), Earley, Laurence E., Merrill, Richard A.
Format: eBook
Language:Inglés
Published: Washington, D.C. : National Academy Press 1992.
Edition:1st ed
Subjects:
Institute of Medicine (U.S.). > Committee to Study the Use of Advisory Committees by the Food and Drug Administration.
Public health advisory groups > United States > Evaluation.
See on Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820335606719
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
  • 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.

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