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
Page : 23 pages
File Size : 55,5 Mb
Release : 2009
Category : Health & Fitness
ISBN : 9781437904345

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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 Pdf

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 : Marcia Crosse
Publisher : Unknown
Page : 19 pages
File Size : 52,9 Mb
Release : 2008
Category : Drugs
ISBN : OCLC:232330615

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Drug Safety by Marcia Crosse Pdf

Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 38 pages
File Size : 54,8 Mb
Release : 2018-05-19
Category : Electronic
ISBN : 1719332193

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Drug Safety by United States Government Accountability Office Pdf

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

Author : Anonim
Publisher : DIANE Publishing
Page : 26 pages
File Size : 44,7 Mb
Release : 2007
Category : Electronic
ISBN : 1422398919

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

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 268 pages
File Size : 43,7 Mb
Release : 2008
Category : Business & Economics
ISBN : UOM:39015085459595

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FDA's Foreign Drug Inspection Program by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations Pdf

Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 58 pages
File Size : 44,7 Mb
Release : 2009-05
Category : Technology & Engineering
ISBN : 9781437911305

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Drug Safety by Marcia Crosse Pdf

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 : Anonim
Publisher : DIANE Publishing
Page : 43 pages
File Size : 48,8 Mb
Release : 2024-06-29
Category : Electronic
ISBN : 9781437941746

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

Author : Valerie C. Melvin
Publisher : DIANE Publishing
Page : 57 pages
File Size : 40,7 Mb
Release : 2009-11
Category : Computers
ISBN : 9781437917376

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Information Technology by Valerie C. Melvin Pdf

The FDA relies heavily on info. tech. (IT) to carry out its responsibility for ensuring the safety and effectiveness of certain consumer products. Recognizing limitations in its IT capabilities that had been previously identified, the agency has begun various initiatives to modernize its IT systems. This report: (1) evaluates the FDA¿s overall plans for modernizing its IT systems, including the extent to which the plans address identified limitations or inadequacies in the agency¿s capabilities; and (2) assesses to what extent the agency has put in place key IT mgmt. policies and processes to guide the implementation of its modernization projects. Includes recommendations. Charts and tables.

Author : Lisa Shames
Publisher : DIANE Publishing
Page : 60 pages
File Size : 54,7 Mb
Release : 2010-08
Category : Political Science
ISBN : 9781437931327

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Food and Drug Administration by Lisa Shames Pdf

Reviews the FDA¿s strategic planning and mgmt. Leading practices in this area include developing strategies to address mgmt. challenges and results-oriented performance measures, aligning activities and resources to strategic goals, and enhancing the use of performance info. The report examined the extent to which: (1) FDA's Strategic Action Plan contains strategies to address its mgmt. challenges, and the progress FDA has reported in addressing those challenges; (2) FDA's annual performance measures are results-oriented; (3) FDA has aligned its activities and resources to support its strategic goals; and (4) FDA managers report using performance info. in decision making and applying key practices to encourage that use. Illustrations.

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 240 pages
File Size : 50,5 Mb
Release : 2008
Category : Cosmetics
ISBN : UOM:39015085459587

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Discussion Draft of the Food and Drug Administration Globalization Act Legislation by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Pdf

Author : Anonim
Publisher : Unknown
Page : 248 pages
File Size : 55,6 Mb
Release : 2010
Category : Electronic
ISBN : MINN:31951D03140315B

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Discussion Draft of the Food and Drug Administration Globalization Act Legislation: Device and Cosmetic Safety Provisions, Serial No. 110-117, May 14, 2008, 110-2 Hearing, * by Anonim Pdf

Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher : Unknown
Page : 96 pages
File Size : 53,6 Mb
Release : 2014
Category : Drug adulteration
ISBN : MINN:31951D036475171

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Securing the Pharmaceutical Supply Chain by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Pdf

Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 26 pages
File Size : 54,9 Mb
Release : 2008-12
Category : Health & Fitness
ISBN : 9781437905274

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Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments by Marcia Crosse Pdf

As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement assesses: (1) FDA¿s program for inspecting foreign establishments that manufacture medical devices for the U.S. market; and (2) FDA¿s programs for third-party inspections of those establishments.

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 : 43,5 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086

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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by 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 Pdf

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 : Gene L. Dodaro
Publisher : DIANE Publishing
Page : 99 pages
File Size : 43,7 Mb
Release : 2009-12
Category : Political Science
ISBN : 9781437913033

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High-Risk Series by Gene L. Dodaro Pdf

The fed. gov¿t. is the world's largest and most complex entity, with about $3 trillion in outlays in FY 2008. Reports on high-risk areas bring focus to areas needing attention due to their greater vulnerabilities to fraud, waste, abuse, and mismanagement. These reports also identify areas needing transformation to address major economy, efficiency, or effectiveness challenges. This 2009 update presents the status of high-risk areas listed in 2007 and identifies new high-risk areas. Solutions to high-risk problems offer the potential to save billions of dollars, dramatically improve service to the public, strengthen confidence and trust in the performance and accountability of the U.S. gov¿t., and ensure the ability of gov¿t. to deliver on its promises. Illus.