Dietary Supplements & FDA Use of Adverse Event Reports

Buch | Softcover

71 Seiten

2013
Nova Science Publishers Inc (Verlag)
978-1-62808-023-0 (ISBN)

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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.

Preface; 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.

Erscheint lt. Verlag	1.7.2013
Verlagsort	New York
Sprache	englisch
Maße	155 x 230 mm
Gewicht	140 g
Themenwelt	Medizin / Pharmazie ► Gesundheitsfachberufe ► Diätassistenz / Ernährungsberatung
	Medizin / Pharmazie ► Pflege
	Studium ► Querschnittsbereiche ► Prävention / Gesundheitsförderung
ISBN-10	1-62808-023-X / 162808023X
ISBN-13	978-1-62808-023-0 / 9781628080230
Zustand	Neuware