Download or read book Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Use of Advisory Committees by the Food and Drug Administration written by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee and published by . This book was released on 1974 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food and Drug Administration Public Advisory Committees written by United States. Food and Drug Administration and published by . This book was released on 1971 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Use of Advisory Committees by the Food and Drug Administration written by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee and published by . This book was released on 1974 with total page 574 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Public Advisory Committees written by United States. Food and Drug Administration and published by . This book was released on 1972 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Final Report of the Advisory Committee on the Food and Drug Administration written by United States. Department of Health and Human Services. Advisory Committee on the Food and Drug Administration and published by . This book was released on 1991 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Public Advisory Committees Authority Structure Functions Members written by United States. Food and Drug Administration and published by . This book was released on 1971 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food and Drug Administration Oversight written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1991 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidance for the Public FDA Advisory Committee Members and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees written by and published by . This book was released on 2008 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Use of Advisory Committees by the Food and Drug Administration Hearings Before a Subcommittee 94 1 Pt 2 written by United States Congress House Commi and published by Legare Street Press. This book was released on 2023-07-18 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this groundbreaking report, the United States Congress examines the role of advisory committees in the Food and Drug Administration's decision-making process. With detailed testimony from industry experts, scientists, and government officials, this report offers a comprehensive overview of the complex regulatory landscape surrounding drug policy in the United States. This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Download or read book Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at FDA written by United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee and published by . This book was released on 1993 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Public Advisory Committees written by United States. Environmental Health Service and published by . This book was released on 1975 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidance for FDA Advisory Committee Members and FDA Staff written by and published by . This book was released on 2008 with total page 6 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Anticancer Drug Development Guide written by Beverly A. Teicher and published by Springer Science & Business Media. This book was released on 2004-02-01 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent. " The recognition following World War I that the administration of toxic chemicals such as nitrogen mustards in a controlled manner could shrink malignant tumor masses for relatively substantial periods of time gave great impetus to the search for molecules that would be lethal to specific cancer cells. Weare still actively engaged in that search today. The question is how to discover these "anticancer" molecules. Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, Second Edition describes the evolution to the present of preclinical screening methods. The National Cancer Institute's high-throughput, in vitro disease-specific screen with 60 or more human tumor cell lines is used to search for molecules with novel mechanisms of action or activity against specific phenotypes. The Human Tumor Colony-Forming Assay (HTCA) uses fresh tumor biopsies as sources of cells that more nearly resemble the human disease. There is no doubt that the greatest successes of traditional chemotherapy have been in the leukemias and lymphomas. Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.
Download or read book Use of Advisory Committees by the Food and Drug Administration written by and published by . This book was released on 1975 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Optimizing the Process for Establishing the Dietary Guidelines for Americans written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-12-16 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal guidance on nutrition and diet is intended to reflect the state of the science and deliver the most reliable recommendations possible according to the best available evidence. This guidance, updated and presented every 5 years in the Dietary Guidelines for Americans (DGA), serves as the basis for all federal nutrition policies and nutrition assistance programs, as well as nutrition education programs. Despite the use of the guidelines over the past 30 years, recent challenges prompted Congress to question the process by which food and nutrition guidance is developed. This report assesses the process used to develop the guidelines; it does not evaluate the substance or use of the guidelines. As part of an overall, comprehensive review of the process to update the DGA, this first report seeks to discover how the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints for the purpose of informing the 2020 cycle.
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
