Author: United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and InvestigationsPublisher:
ISBN:
Category : Law
Languages : en
Pages : 88
Book Description
FDA Integrity Issues
Author: United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and InvestigationsPublisher:
ISBN:
Category : Law
Languages : en
Pages : 88
Book Description
Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309172802
Category : Medical
Languages : en
Pages : 88
Book Description
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.
Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309218160
Category : Medical
Languages : en
Pages : 292
Book Description
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.
FDA in the Twenty-First Century
Author: Holly Fernandez LynchPublisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499
Book Description
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
FDA Investigations Operations Manual
Author: Food and Drug AdministrationPublisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
Book Description
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Data Integrity and Data Governance
Author: R. D. McDowallPublisher: Royal Society of Chemistry
ISBN: 178801281X
Category : Science
Languages : en
Pages : 660
Book Description
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Food and Drug Administration Advisory Committees
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
Book Description
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.
FDA Biotechnology Inspection Guide
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
Book Description
FDA Integrity Issues
Author: United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and InvestigationsPublisher:
ISBN:
Category : Law
Languages : en
Pages : 88
Book Description
The Adequacy of FDA to Assure the Safety of the Nation's Drug Supply
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and InvestigationsPublisher:
ISBN:
Category : Medical
Languages : en
Pages : 324
Book Description