Fda S Foreign Drug Inspection Program

Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 58 pages
File Size : 50,7 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 : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 268 pages
File Size : 43,9 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 : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 128 pages
File Size : 45,9 Mb
Release : 2008
Category : Electronic
ISBN : OCLC:1231226762

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FDA 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 : 23 pages
File Size : 45,6 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 : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 64 pages
File Size : 41,9 Mb
Release : 2017-09-23
Category : Electronic
ISBN : 1977507751

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Drug Safety by United States Government Accountability Office Pdf

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 : Bernice Steinhardt
Publisher : DIANE Publishing
Page : 148 pages
File Size : 41,7 Mb
Release : 1999-04
Category : Electronic
ISBN : 0788178598

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Food and Drug Administration by Bernice Steinhardt Pdf

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.

Author : U.s. Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 64 pages
File Size : 42,8 Mb
Release : 2017-07-25
Category : Drugs
ISBN : 1973913623

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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 Pdf

" 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 : Anonim
Publisher : DIANE Publishing
Page : 26 pages
File Size : 45,8 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 : Anonim
Publisher : DIANE Publishing
Page : 43 pages
File Size : 47,6 Mb
Release : 2024-07-01
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 : U.s. Government Accountability Office
Publisher : Unknown
Page : 44 pages
File Size : 41,9 Mb
Release : 2017-08-17
Category : Electronic
ISBN : 1974622096

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Drug Safety by U.s. Government Accountability Office Pdf

"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 : Food and Drug Administration
Publisher : Unknown
Page : 0 pages
File Size : 49,5 Mb
Release : 2003
Category : Drugs
ISBN : 0865879737

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FDA Investigations Operations Manual by Food and Drug Administration Pdf

Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.

Author : Anonim
Publisher : Unknown
Page : 0 pages
File Size : 43,7 Mb
Release : 2008
Category : Drugs
ISBN : OCLC:271859176

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Drug Safety by Anonim Pdf

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.

Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 58 pages
File Size : 52,8 Mb
Release : 2018-01-17
Category : Electronic
ISBN : 1983923044

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Drug Safety by United States Government Accountability Office Pdf

Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program

Author : United States. Government Accountability Office
Publisher : Unknown
Page : 53 pages
File Size : 52,6 Mb
Release : 2008
Category : Electronic
ISBN : OCLC:271859176

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Drug Safety by United States. Government Accountability Office Pdf

Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 30 pages
File Size : 46,6 Mb
Release : 2008-05
Category : Business & Economics
ISBN : 9781437900200

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Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections by Marcia Crosse Pdf

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.