Drug Safety Preliminary Findings Suggest Weaknesses In Fdas Program For Inspecting Foreign Drug Manufacturers

Author :
Publisher : DIANE Publishing
ISBN 13 : 9781422398913
Total Pages : 26 pages
Book Rating : 4.19/5 ( download)

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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:

Author : Marcia Crosse
Publisher : DIANE Publishing
ISBN 13 : 1437904343
Total Pages : 23 pages
Book Rating : 4.45/5 ( download)

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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.

Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781983852343
Total Pages : 28 pages
Book Rating : 4.41/5 ( download)

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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 2018-01-15 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety: Preliminary Findings Suggest Weaknesses in FDA's Program for Inspecting Foreign Drug Manufacturers

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher :
ISBN 13 :
Total Pages : 268 pages
Book Rating : 4.95/5 ( download)

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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:

Author :
Publisher : DIANE Publishing
ISBN 13 : 1437941745
Total Pages : 43 pages
Book Rating : 4.46/5 ( download)

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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:

Author : Marcia Crosse
Publisher : DIANE Publishing
ISBN 13 : 1437900208
Total Pages : 30 pages
Book Rating : 4.00/5 ( download)

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Download or read book Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections written by Marcia Crosse and published by DIANE Publishing. This book was released on 2008-05 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: As part of the FDA¿s oversight of the safety & effectiveness of medical devices marketed in the U.S., it inspects domestic & foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee & Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. This statement: (1) assesses FDA¿s mgmt. of inspections of establishments -- particularly those in foreign countries -- manufacturing devices for the U.S. market; & (2) provides the status of FDA¿s programs for third-party inspections of medical device manufacturing establishments. Illustrations.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030922408X
Total Pages : 366 pages
Book Rating : 4.86/5 ( download)

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Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher :
ISBN 13 :
Total Pages : 432 pages
Book Rating : 4.90/5 ( download)

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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:

Author : Marcia Crosse
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.29/5 ( download)

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Download or read book Drug Safety written by Marcia Crosse and published by . This book was released on 2007 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Mark J. Green
Publisher : Basic Books (AZ)
ISBN 13 : 0465013872
Total Pages : 706 pages
Book Rating : 4.76/5 ( download)

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Download or read book Change for America written by Mark J. Green and published by Basic Books (AZ). This book was released on 2009-01-01 with total page 706 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contributors representing two of the nation's most widely respected think tanks provide an agency-by-agency blueprint for building a new administration and rebuilding America.