Dietary Supplements and FDA Use of Adverse Event Reports, Paperback by Forsberg, William M. (EDT), ISBN 162808023X, ISBN-13 9781628080230, Brand New, Free shipping in the US
Oops! Looks like we're having trouble connecting to our server.
Refresh your browser window to try again.
About this product
Product Identifiers
PublisherNOVA Science Publishers, Incorporated
ISBN-10162808023X
ISBN-139781628080230
eBay Product ID (ePID)11038549891
Product Key Features
Number of Pages71 Pages
Publication NameDietary Supplements and Fda Use of Adverse Event Reports
LanguageEnglish
Publication Year2013
SubjectNutrition, Diet & Nutrition / General, American Government / National
TypeTextbook
Subject AreaPolitical Science, Health & Fitness, Medical
AuthorWilliam M. Forsberg
FormatTrade Paperback
Dimensions
Item Weight4.9 Oz
Item Length9.1 in
Item Width6.1 in
Additional Product Features
LCCN2013-431353
IllustratedYes
Table Of ContentPreface; Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products; For Industry: Dietary Supplements -- Reporting an Adverse Event At a Glance; Q&A on Dietary Supplements; The Publics Stake in Adverse Event Reporting; Index.
SynopsisManufacturers, 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.