Download or read book Drug Safety written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-09-23 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization has complicated FDA's oversight of drugs marketed in the United States. FDA reports that more than 40 percent of finished drugs and 80 percent of active pharmaceutical ingredients are produced overseas. FDA inspects drug manufacturing establishments to ensure that the safety and quality of drugs are not jeopardized by poor manufacturing practices. Beginning in 2008, FDA established foreign offices to obtain better information on products coming from overseas and perform inspections, among other things. In 2008 and 2010, GAO examined FDA's foreign drug inspection program and recommended it conduct more foreign inspections. In another 2010 report, GAO recommended the agency develop strategic and workforce plans for its foreign offices. GAO was asked to update its work with a focus on FDA's oversight of foreign drug establishments. This study examines (1) enhancements FDA has made to its foreign drug inspection program; and (2) FDA's assessment of its foreign offices, and the challenges they face in ensuring drug safety. GAO analyzed FDA's inspection data from fiscal year 2007 through June 30, 2016; reviewed agency planning documents; and interviewed FDA officials, including former foreign office employees.
Download or read book Drug Safety Fda Has Improved Its Foreign Drug Inspection Program But Needs to Assess the Effectiveness and Staffing of Its Foreign Offices written by U.s. Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-07-25 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: " Globalization has complicated FDA's oversight of drugs marketed in the United States. FDA reports that more than 40 percent of finished drugs and 80 percent of active pharmaceutical ingredients are produced overseas. FDA inspects drug manufacturing establishments to ensure that the safety and quality of drugs are not jeopardized by poor manufacturing practices. Beginning in 2008, FDA established foreign offices to obtain better information on products coming from overseas and perform inspections, among other things. In 2008 and 2010, GAO examined FDA's foreign drug inspection program and recommended it conduct more foreign inspections. In another 2010 report, GAO recommended the agency develop strategic and workforce plans for its foreign offices. GAO was asked to update its work with a focus on FDA's oversight of foreign drug establishments. This study examines (1) enhancements FDA has made to its foreign drug inspection program; and (2) FDA's assessment of its foreign offices, and the challenges they face in ensuring drug safety. GAO analyzed FDA's inspection data from fiscal year 2007 through June 30, 2016; reviewed agency planning documents; and interviewed FDA officials, including former foreign office employees. "
Download or read book Report to Congress of the U S China Economic and Security Review Commission written by U.S.-China Economic and Security Review Commission and published by . This book was released on 2019 with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Safety FDA has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments but More Progress Is Needed written by and published by DIANE Publishing. This book was released on with total page 43 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Good Manufacturing Practices for Pharmaceuticals Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Download or read book Agriculture Rural Development Food and Drug Administration and Related Agencies Appropriations for 2018 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2017 with total page 1026 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Safety Preliminary Findings Suggest Recent FDA Initiatives Have Potential But Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program written by Marcia Crosse and published by DIANE Publishing. This book was released on 2009 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: The FDA is responsible for overseeing the safety and effectiveness of human drugs that are marketed in the U.S., whether they are manufactured in foreign or domestic estab. FDA inspects foreign estab. to ensure that they meet the same standards required of domestic estab. Ongoing concerns regarding FDA¿s foreign drug inspection program recently were heightened when FDA learned that contaminated doses of a common blood thinner had been manufactured at a Chinese estab. that the agency had never inspected. FDA has announced initiatives to improve its foreign drug inspection program. This statement presents preliminary findings on how FDA¿s initiatives address the weaknesses that have been identified. Illustrations.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book Political Power in America written by Anthony R. DiMaggio and published by SUNY Press. This book was released on 2019-12-01 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to American politics that provides a critical examination of both political institutions and political behavior. Analyzing major political institutions such as Congress, the courts, the presidency, and the media, this book chronicles how the interests of affluent Americans—particularly business, professional, and corporate interests—dominate over those of “average” citizens. Anthony R. DiMaggio examines American political behavior, as it relates to lobbying, citizen activism, media consumption, and voting, to demonstrate how the public is often misinformed and manipulated regarding major political and economic matters. However, record public distrust of the government and the increasing popularity of mass protests suggest that most Americans are deeply unhappy with the political status quo, and many are willing to fight for change. Political Power in America details this interplay between a political system dominated by the affluent few and the rise of mass political distrust and protest. It offers information and tools needed to better understand the democratic deficit in American politics, while providing opportunities for discussing what we might do to address the mounting crisis of declining democracy. “An original and refreshing introductory text on the United States political system. The originality, coupled with an accessibility of critical concepts, makes this book truly one of a kind.” — Mark Major, author of The Unilateral Presidency and the News Media: The Politics of Framing Executive Power
Download or read book Jonas Introduction to the U S Health Care System written by Raymond L. Goldsteen, DrPH and published by Springer Publishing Company. This book was released on 2024-05-15 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its 10th edition, this best-selling introductory text, valued for its balanced overview of the U.S. health care system, has been fully updated to help students stay at the forefront of the dynamic and complex health care field. Jonas' Introduction to the U.S. Health Care System continues to offer a foundational framework that concisely explains the core elements and functions of the system. The text provides an essential understanding of the current state of the health care system, as well as the factors influencing its future state. Students also benefit from the special emphasis given to the evolution of the health care system and to identification of the underlying values that influence health care policy. Well-organized and easily accessible, the 10th edition prepares the next generation of health care leaders—from health care management, public health, medicine, nursing, allied health, and health policy—to comprehend the variety of forces that shape the field in which they will practice so they can navigate change and improve the health system's record on quality, safety, value, access, and equity. New to the 10th Edition: Expanded coverage of telehealth, advanced consumer medical devices, apps, and remote patient monitoring Updated treatment of the social and political determinants of health Discussion of the COVID-19 pandemic including the health care system's resiliency in the face of adversity Updated content on the diverse health care workforce and its functions Discussion of important financing issues including value-based care and alternative payment models as well as the impact of private equity funding, consolidation, and consumerism Significantly updated sections across the continuum of care including self-care, adult day services, hospice, long-term care, and others Key Features The most concise and balanced introduction to the U.S. health care system Engaging visual content including cartoons, graphs, and tables that consolidate key information about health care system performance, workforce trends, health care financing, and policy changes Qualified instructors have access to this edition's expanded Instructor Resources featuring new learning activities, engaging case studies, and additional resources to supplement students' dynamic learning and interaction with the text
Download or read book FDA s Foreign Drug Inspection Program written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2008 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Foreign Drug Inspection Program written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2008 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Safety Preliminary Findings Suggest Weaknesses in FDA s Program for Inspecting Foreign Drug Manufacturers written by and published by DIANE Publishing. This book was released on 2007 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Download or read book Securing the Pharmaceutical Supply Chain written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2014 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Agriculture Rural Development Food and Drug Administration and Related Agencies Appropriations for 2015 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2014 with total page 1096 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book National Commission on Product Safety Extension and Child Protection Act written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Commerce and Finance and published by . This book was released on 1969 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt:
