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Author: William M. Forsberg Publisher: Nova Science Publishers ISBN: 9781628080230 Category : Health & Fitness Languages : en Pages : 0
Book Description
Manufacturers, packers, and distributors of dietary supplements in the United States are required to report information about serious adverse effects associated with the use of these supplements to the Food and Drug Administration (FDA). The FDA carefully considers all the available safety information submitted to the agency before a product is approved. However, unexpected and sometimes serious safety problems can emerge once a product goes to market and is used by millions of people. As a result, post-market safety monitoring, that is, analysing information on products once they go to market, is a critical part of the FDA's responsibilities. The public provides an important source of such safety information. Health care facilities, practitioners, and patients submit reports to the FDA and to manufacturers on advise events, medical errors, and product quality problems observed during the use of a product. This book examines the number of adverse event reports the FDA has received since 2008; their source and types of products identified, and the actions the FDA has taken to ensure that firms are complying with adverse event report requirements.
Author: William M. Forsberg Publisher: Nova Science Publishers ISBN: 9781628080230 Category : Health & Fitness Languages : en Pages : 0
Book Description
Manufacturers, packers, and distributors of dietary supplements in the United States are required to report information about serious adverse effects associated with the use of these supplements to the Food and Drug Administration (FDA). The FDA carefully considers all the available safety information submitted to the agency before a product is approved. However, unexpected and sometimes serious safety problems can emerge once a product goes to market and is used by millions of people. As a result, post-market safety monitoring, that is, analysing information on products once they go to market, is a critical part of the FDA's responsibilities. The public provides an important source of such safety information. Health care facilities, practitioners, and patients submit reports to the FDA and to manufacturers on advise events, medical errors, and product quality problems observed during the use of a product. This book examines the number of adverse event reports the FDA has received since 2008; their source and types of products identified, and the actions the FDA has taken to ensure that firms are complying with adverse event report requirements.
Author: Michael F. Mangano Publisher: ISBN: 9780756712365 Category : Medical Languages : en Pages : 100
Book Description
Assesses the effectiveness of the FDA's AER system for DS in protecting the Amer. consumer. 60% of Amer. take some form of DS every day without any problems. They include vit., minerals, botanicals, and amino acids. FDA does not have the authority to require DS to undergo pre-market approval for safety and efficacy. Instead, it relies mostly on its AER system to identify safety problems. However, FDA lacks key med., product, mfr., trend, and clinical info. to generate signals of public health concerns from the AER system. Offers actions that FDA can take to strengthen its ability to detect adverse events, appropriately assess reported events, and disclose more useful info. to the public.
Author: Lisa Shames Publisher: DIANE Publishing ISBN: 1437914993 Category : Health & Fitness Languages : en Pages : 77
Book Description
Dietary supplements (DS) and foods with added dietary ingred., such as vitamins and herbs, are multibillion dollar industries. Past reports on the FDA¿s reg¿n. of these products raised concerns about product safety and the availability of reliable info. Since then, FDA published draft guidance on requirements for reporting adverse events -- which are harmful effects or illnesses -- and Current Good Mfg. Practice reg¿s. for DS. This report examines FDA's: (1) actions to respond to the new serious adverse event reporting require.;(2) ability to identify and act on concerns about the safety of DS, and the safety of foods with added dietary ingred.; and (3) actions to ensure that consumers have useful info. about the safety and efficacy of DS. Illustrations.
Author: Office of Inspector (Oig) Publisher: ISBN: 9781296044718 Category : Languages : en Pages : 114
Book Description
This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work.As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Author: United States. Department of Health and Human Services. Office of Inspector General Publisher: ISBN: Category : Consumer protection Languages : en Pages : 100
Author: National Research Council Publisher: National Academies Press ISBN: 0309091101 Category : Medical Languages : en Pages : 527
Book Description
The growing consumer interest in health and fitness has expanded the market for a wide range of products, from yoga mats to the multiple dietary supplements now on the market. Supplements are popular, but are they safe? Many dietary supplements are probably safe when used as recommended. However, since 1994 when Congress decided that they should be regulated as if they were foods, they are assumed to be safe unless the Food and Drug Administration can demonstrate that they pose a significant risk to the consumer. But there are many types of products that qualify as dietary supplements, and the distinctions can become muddled and vague. Manufacturers are not legally required to provide specific information about safety before marketing their products. And the sales of supplements have been steadily increasingâ€"all together, the various types now bring in almost $16 billion per year. Given these confounding factors, what kind of information can the Food and Drug Administration use to effectively regulate dietary supplements? This book provides a framework for evaluating dietary supplement safety and protecting the health of consumers.
Author: William M. Forsberg
Author: William M. Forsberg
Author: Michael F. Mangano
Author: United States. Department of Health and Human Services. Office of Inspector General
Author: Lisa Shames
Author: 
Author: 
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Author: Office of Inspector (Oig)
Author: United States. Department of Health and Human Services. Office of Inspector General
Author: National Research Council