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Author : Anonim
Publisher : DIANE Publishing
Page : 43 pages
File Size : 40,7 Mb
Release : 2024-07-01
Category : Electronic
ISBN : 9781437941746
Author : United States. Government Accountability Office
Publisher : Unknown
Page : 38 pages
File Size : 44,6 Mb
Release : 2010
Category : Drugs
ISBN : OCLC:730233606
Author : U.s. Government Accountability Office
Publisher : Unknown
Page : 44 pages
File Size : 55,8 Mb
Release : 2017-08-17
Category : Electronic
ISBN : 1974622096
"Globalization has placed increasing demands on the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), in ensuring the safety and effectiveness of drugs marketed in the United States. Drugs manufactured in more than 100 countries were offered for entry into the United States in fiscal year 2009. FDA inspects drug manufacturing establishments in order to ensure that the safety and quality of drugs are not jeopardized by poor manufacturing practices.In 1998 GAO identified weaknesses in FDA's foreign drug inspection program. In 2008 GAO found, among other things, that from fiscal years 2002 through 2007, FDA inspected relatively few foreign establishments each year. GAO also determined that, because of inaccurate information in its databases, FDA did not know how many foreign drug establishments were subject to inspection.In 2008 GAO recommended that FDA increase inspections of foreign drug establishments and improve information it receives to manage the foreign drug inspection program. This report examines FDA's progress since 2008 in (1) conducting more foreign drug inspections, and (2) improving its information on foreign drug establishments. GAO analyzed information from FDA databases, reviewed documents related to FDA's efforts to both improve these..."
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 58 pages
File Size : 54,5 Mb
Release : 2009-05
Category : Technology & Engineering
ISBN : 9781437911305
The FDA oversees the safety and effectiveness of human drugs marketed in the U.S., including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines: (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection; (2) the frequency of foreign inspections; and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. The author analyzed info. from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials. Includes recommendations. Illus.
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 52 pages
File Size : 43,8 Mb
Release : 2011-05
Category : Reference
ISBN : 9781437941739
An increasing volume of food and medical products marketed in the U.S. are produced in foreign countries. This globalization has challenged the FDA, which is responsible for ensuring the safety of these products. In late 2008 and early 2009, FDA established overseas offices comprised of 42 total staff covering particular countries or regions. The offices develop info. that FDA officials can use to make better decisions about products manufactured in foreign countries, among other activities. This report examined: (1) the steps overseas offices have taken to help ensure the safety of imported products; and (2) the extent to which FDA has engaged in long-term strategic and workforce planning for the overseas offices. Charts and tables. A print on demand report.
Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 64 pages
File Size : 53,5 Mb
Release : 2017-09-23
Category : Electronic
ISBN : 1977507751
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.
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher : Unknown
Page : 348 pages
File Size : 46,8 Mb
Release : 2012
Category : United States
ISBN : MINN:31951D03502165Q
Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher : Unknown
Page : 96 pages
File Size : 54,9 Mb
Release : 2014
Category : Drug adulteration
ISBN : MINN:31951D036475171
Author : Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Publisher : National Academies Press
Page : 366 pages
File Size : 49,8 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086
A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Author : Anonim
Publisher : DIANE Publishing
Page : 183 pages
File Size : 40,7 Mb
Release : 2024-07-01
Category : Electronic
ISBN : 9781437981780
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 212 pages
File Size : 45,9 Mb
Release : 2013
Category : Biological products
ISBN : MINN:31951D03670965R
Author : Rena Steinzor
Publisher : Cambridge University Press
Page : 295 pages
File Size : 48,6 Mb
Release : 2015
Category : Law
ISBN : 9781107053403
The US Department of Justice is under fire for failing to prosecute banks that caused the 2008 economic meltdown because they are too big to jail. Prosecutors have long neglected to hold corporate executives accountable for chronic mistakes that kill and injure workers and customers. This book, the first of its kind, analyzes five industrial catastrophes that have killed or sickened consumers and workers or caused irrevocable harm to the environment. From the Texas City refinery explosion to the Upper Big Branch mine collapse, the root causes of these preventable disasters include crimes of commission and omission. Although federal prosecutors have made a start on holding low-level managers liable, far more aggressive prosecution is appropriate as a matter of law, policy, and justice. Written in accessible and jargon-free language, this book recommends innovative interpretations of existing laws to elevate the prosecution of white-collar crime at the federal and state levels.
Author : Hammaker,Thomas M. Knadig
Publisher : Jones & Bartlett Learning
Page : 881 pages
File Size : 53,6 Mb
Release : 2017-03-02
Category : Law
ISBN : 9781284117349
Health Care Management and the Law-2nd Edition is a comprehensive practical health law text relevant to students seeking the basic management skills required to work in health care organizations, as well as students currently working in health care organizations. This text is also relevant to those general health care consumers who are simply attempting to navigate the complex American health care system. Every attempt is made within the text to support health law and management theory with practical applications to current issues.
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 23 pages
File Size : 54,9 Mb
Release : 2009
Category : Health & Fitness
ISBN : 9781437904345
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.
Author : U.s. Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 64 pages
File Size : 43,5 Mb
Release : 2017-07-25
Category : Drugs
ISBN : 1973913623
" 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. "