Fda S Foreign Drug Inspection Program
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Fda Foreign Drug Inspection Program
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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
language : en
Publisher:
Release Date : 2008
Fda Foreign Drug Inspection Program written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Business & Economics categories.
Fda S Foreign Drug Inspection Program
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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
language : en
Publisher:
Release Date : 2008
Fda S Foreign Drug Inspection Program written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Business & Economics categories.
Drug Safety Preliminary Findings Suggest Weaknesses In Fda S Program For Inspecting Foreign Drug Manufacturers
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Author :
language : en
Publisher: DIANE Publishing
Release Date : 2007
Drug Safety Preliminary Findings Suggest Weaknesses In Fda S Program For Inspecting Foreign Drug Manufacturers written by and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with categories.
Drug Safety
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Author : Marcia Crosse
language : en
Publisher: DIANE Publishing
Release Date : 2009-05
Drug Safety written by Marcia Crosse and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-05 with Technology & Engineering categories.
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.
Drug Safety Preliminary Findings Suggest Recent Fda Initiatives Have Potential But Do Not Fully Address Weaknesses In Its Foreign Drug Inspection Program
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Author : Marcia Crosse
language : en
Publisher: DIANE Publishing
Release Date : 2009
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 has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Health & Fitness categories.
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.
Drug Safety Fda Has Improved Its Foreign Drug Inspection Program But Needs To Assess The Effectiveness And Staffing Of Its Foreign Offices
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Author : U.s. Government Accountability Office
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-07-25
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 has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-25 with Drugs categories.
" 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. "
Drug Safety
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Author : United States Government Accountability Office
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-09-23
Drug Safety written by United States Government Accountability Office and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-23 with categories.
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.
Drug Safety Fda Has Conducted More Foreign Inspections And Begun To Improve Its Information On Foreign Establishments But More Progress Is Needed
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Author :
language : en
Publisher: DIANE Publishing
Release Date :
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 has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Drug Safety
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Author : U.s. Government Accountability Office
language : en
Publisher:
Release Date : 2017-08-17
Drug Safety written by U.s. Government Accountability Office and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-17 with categories.
"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..."
Food And Drug Administration
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Author : Bernice Steinhardt
language : en
Publisher: DIANE Publishing
Release Date : 1999-04
Food And Drug Administration written by Bernice Steinhardt and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-04 with categories.
Examines FDA's efforts to: prepare inspection reports & take enforcement actions against foreign pharmaceutical manufacturers in a timely manner; improve the consistency with which FDA evaluates the results of foreign inspections & conducts reinspections to verify that foreign pharmaceutical manufacturers have corrected serious deficiencies; conduct routine inspections of foreign pharmaceutical manufacturers to monitor their compliance with U.S. quality standards; & improve the management of data needed for planning inspection, monitoring inspection results, & taking enforcement actions. Charts & tables.