Food and Drug Administration Advisory Committees
Seiten
1992
National Academies Press (Verlag)
978-0-309-04837-8 (ISBN)
National Academies Press (Verlag)
978-0-309-04837-8 (ISBN)
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. This volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices.
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.
Table of Contents
Front Matter
Summary
1 Introduction
2 Historical Evolution of FDA Advisory Committees
3 The FDA Advisory Committee System
4 Recurring Issues
5 Committee Membership
6 Ensuring Committee Integrity
7 Committee Operations
8 Organization and Management
A Resource Implications
B Glossary
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.
Table of Contents
Front Matter
Summary
1 Introduction
2 Historical Evolution of FDA Advisory Committees
3 The FDA Advisory Committee System
4 Recurring Issues
5 Committee Membership
6 Ensuring Committee Integrity
7 Committee Operations
8 Organization and Management
A Resource Implications
B Glossary
Richard A. Rettig, Laurence E. Earley, and Richard A. Merrill, Editors; Committee to Study the Use of Advisory Committees, Institute of Medicine
1 Front Matter; 2 Summary; 3 1 Introduction; 4 2 Historical Evolution of FDA Advisory Committees; 5 3 The FDA Advisory Committee System; 6 4 Recurring Issues; 7 5 Committee Membership; 8 6 Ensuring Committee Integrity; 9 7 Committee Operations; 10 8 Organization and Management; 11 A Resource Implications; 12 B Glossary
| Erscheint lt. Verlag | 1.2.1992 |
|---|---|
| Verlagsort | Washington |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Themenwelt | Medizin / Pharmazie ► Gesundheitswesen |
| Sozialwissenschaften ► Politik / Verwaltung ► Politische Systeme | |
| Sozialwissenschaften ► Politik / Verwaltung ► Politische Theorie | |
| Sozialwissenschaften ► Politik / Verwaltung ► Staat / Verwaltung | |
| ISBN-10 | 0-309-04837-0 / 0309048370 |
| ISBN-13 | 978-0-309-04837-8 / 9780309048378 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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