Institute of Medicine, Committee to Study the Use of's Food and Drug Administration Advisory Committees PDF

By Institute of Medicine, Committee to Study the Use of Advisory Committees, Richard A. Merrill, Laurence E. Earley, Richard A. Rettig

ISBN-10: 0309048370

ISBN-13: 9780309048378

ISBN-10: 0585085501

ISBN-13: 9780585085500

Like many different organisations of the government, the nutrition and Drug management (FDA) is predicated largely on exterior advisory committees for autonomous clinical and technical recommendation. spotting that the present advisory committee approach is basically sound, this quantity recommends methods of improving using those committees within the review of substances, organic fabrics, and scientific units; strengthening the agency's administration of the method; and extending the responsibility of the approach to the general public. In doing so, it examines and makes tips about such concerns because the recruitment of committee contributors, the FDA's administration of monetary clash of curiosity and highbrow bias between contributors, and the operations and administration of the advisory committee approach.

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Extra resources for Food and Drug Administration Advisory Committees

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Page 13 The IOM committee recommends that the FDA, with the cooperation of OSCE, adopt a policy of strict scheduling for processing waivers and that such a policy include default rules for late submissions of waivers. Sixth, the FDA must update the training programs of its officials with responsibility for implementing conflict of interest policies involving advisory committee members. These training programs should build around the substantive and procedural changes suggested above. Participation should be required of all FDA professional staff who deal with advisory committee members.

It also thanks the many division directors and executive secretaries who gave generously of their time in interviews by the project staff. Our special thanks go to James Weixel, project officer, and Stuart L. Nightingale, who oversaw the study. Page x in interviews by the project staff. Our special thanks go to James Weixel, project officer, and Stuart L. Nightingale, who oversaw the study. In her capacity as Director of the Division of Health Sciences Policy, Ruth Ellen Bulger provided valuable guidance over the duration of the project.

Nevertheless, although the IOM committee has not examined in great detail the impact of this proposal on FDA reviewer time or its budgetary implications, it regards the benefits of advance scheduling of meetings and agenda items as outweighing most potential disadvantages. The IOM committee recommends that FDA adopt a policy of annual advance scheduling of advisory committee meetings and of meeting agendas, with review cycles having deadlines for sponsor submission of data, FDA completion of reviews, and advance distribution of materials to committee members.

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Food and Drug Administration Advisory Committees by Institute of Medicine, Committee to Study the Use of Advisory Committees, Richard A. Merrill, Laurence E. Earley, Richard A. Rettig


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