Author: Publisher: DIANE Publishing
ISBN: 9781422398913
Category :
Languages : en
Pages : 26
Book Description
Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers
Author: Publisher: DIANE Publishing
ISBN: 9781422398913
Category :
Languages : en
Pages : 26
Book Description
Drug Safety
Author: United States Government Accountability OfficePublisher: Createspace Independent Publishing Platform
ISBN: 9781983852343
Category :
Languages : en
Pages : 28
Book Description
Drug Safety: Preliminary Findings Suggest Weaknesses in FDA's Program for Inspecting Foreign Drug Manufacturers
Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, But Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program
Author: Marcia CrossePublisher: DIANE Publishing
ISBN: 1437904343
Category : Health & Fitness
Languages : en
Pages : 23
Book Description
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
Author: Marcia CrosseDrug Safety
Author: United States Government Accountability OfficePublisher: Createspace Independent Publishing Platform
ISBN: 9781719280853
Category :
Languages : en
Pages : 38
Book Description
Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 030922408X
Category : Medical
Languages : en
Pages : 366
Book Description
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.
Drug Safety
Author: Change for America
Author: Mark J. GreenPublisher: Basic Books (AZ)
ISBN: 0465013872
Category : Political Science
Languages : en
Pages : 706
Book Description
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.
Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Author: Marcia CrossePublisher: DIANE Publishing
ISBN: 1437905277
Category : Health & Fitness
Languages : en
Pages : 26
Book Description
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.
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
ISBN: 1437941745
Category :
Languages : en
Pages : 43
Book Description