Quality Of Scientific Evidence In Fda Regulatory Decisions
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Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1999-07-27
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-07-27 with Medical categories.
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author :
language : en
Publisher:
Release Date : 1999
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999 with Clinical trials categories.
Quality Of Scientific Evidence In Fda Regulatory Decisions
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Author : United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
language : en
Publisher:
Release Date : 1978
Quality Of Scientific Evidence In Fda Regulatory Decisions written by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1978 with Government publications categories.
Quality Of Scientific Evidence In Fda Regulatory Decisions
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Author : United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
language : en
Publisher:
Release Date : 1978
Quality Of Scientific Evidence In Fda Regulatory Decisions written by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1978 with Oral contraceptives categories.
Quality Of Scientific Evidence In Fda Regulatory Decisions
DOWNLOAD
Author : United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
language : en
Publisher:
Release Date : 1978
Quality Of Scientific Evidence In Fda Regulatory Decisions written by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1978 with Government publications categories.
Evaluation Of Biomarkers And Surrogate Endpoints In Chronic Disease
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-06-25
Evaluation Of Biomarkers And Surrogate Endpoints In Chronic Disease written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-06-25 with Medical categories.
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-07-30
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-30 with Medical categories.
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.
Sharing Clinical Trial Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20
Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Public Health Effectiveness Of The Fda 510 K Clearance Process
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-10-04
Public Health Effectiveness Of The Fda 510 K Clearance Process written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-04 with Medical categories.
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-04-04
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-04 with Medical categories.
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.