Author : William M. Forsberg
Publisher : Nova Science Publishers
ISBN 13 : 9781628080230
Total Pages : 0 pages
Book Rating : 4.0/5 (82 download)
Book Synopsis Dietary Supplements and FDA Use of Adverse Event Reports by : William M. Forsberg
Download or read book Dietary Supplements and FDA Use of Adverse Event Reports written by William M. Forsberg and published by Nova Science Publishers. This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
