Drug Safety

Drug Safety

Author: United States Government Accountability Office

Publisher: Createspace Independent Publishing Platform

Published: 2017-09-23

Total Pages: 64

ISBN-13: 9781977507754

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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.


Book Synopsis Drug Safety by : United States Government Accountability Office

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.

Drug Safety, Fda Has Improved Its Foreign Drug Inspection Program, But Needs to Assess the Effectiveness and Staffing of Its Foreign Offices

Drug Safety, Fda Has Improved Its Foreign Drug Inspection Program, But Needs to Assess the Effectiveness and Staffing of Its Foreign Offices

Author: U.s. Government Accountability Office

Publisher: Createspace Independent Publishing Platform

Published: 2017-07-25

Total Pages: 64

ISBN-13: 9781973913627

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" 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. "


Book Synopsis Drug Safety, Fda Has Improved Its Foreign Drug Inspection Program, But Needs to Assess the Effectiveness and Staffing of Its Foreign Offices by : U.s. Government Accountability Office

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. "

Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers

Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers

Author:

Publisher: DIANE Publishing

Published: 2007

Total Pages: 26

ISBN-13: 9781422398913

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Book Synopsis Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers by :

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:

Report to Congress of the U.S.-China Economic and Security Review Commission

Report to Congress of the U.S.-China Economic and Security Review Commission

Author: U.S.-China Economic and Security Review Commission

Publisher:

Published: 2019

Total Pages: 596

ISBN-13:

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Book Synopsis Report to Congress of the U.S.-China Economic and Security Review Commission by : U.S.-China Economic and Security Review Commission

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:

Drug Safety

Drug Safety

Author: Marcia Crosse

Publisher: DIANE Publishing

Published: 2009-05

Total Pages: 58

ISBN-13: 1437911307

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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.


Book Synopsis Drug Safety by : Marcia Crosse

Download or read book Drug Safety written by Marcia Crosse and published by DIANE Publishing. This book was released on 2009-05 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, But Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program

Author: Marcia Crosse

Publisher: DIANE Publishing

Published: 2009

Total Pages: 23

ISBN-13: 1437904343

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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.


Book Synopsis Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, But Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program by : Marcia Crosse

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.

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Author: Graham P. Bunn

Publisher: CRC Press

Published: 2019-02-04

Total Pages: 371

ISBN-13: 1498732070

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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.


Book Synopsis Good Manufacturing Practices for Pharmaceuticals, Seventh Edition by : Graham P. Bunn

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 371 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.

Drug Safety: FDA has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed

Drug Safety: FDA has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed

Author:

Publisher: DIANE Publishing

Published:

Total Pages: 43

ISBN-13: 1437941745

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Book Synopsis Drug Safety: FDA has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed by :

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:

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2018

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2018

Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

Publisher:

Published: 2017

Total Pages: 1026

ISBN-13:

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Book Synopsis Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2018 by : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

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:

Drug Safety

Drug Safety

Author: U.s. Government Accountability Office

Publisher:

Published: 2017-08-17

Total Pages: 44

ISBN-13: 9781974622092

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"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..."


Book Synopsis Drug Safety by : U.s. Government Accountability Office

Download or read book Drug Safety written by U.s. Government Accountability Office and published by . This book was released on 2017-08-17 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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..."