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Diane Publishing Books
Adverse Event Reporting (AER) for Dietary Supplements (DS): An Inadequate Safety Valve
Michael F. Mangano. 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, & amino acids. FDA does not have the authority to require DS to undergo pre-market approval for safety & efficacy. Instead, it relies mostly on its AER system to identify safety problems. However, FDA lacks key med., product, mfr., trend, & 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, & disclose more useful info. to the public.
Yukon Alone: The World’s Toughest Adventure Race
Gershwin in His Time: A Biographical Scrapbook, 1919-1937
Dress Codes: Meanings & Messages in American Culture
Guide to Homoeopathy
Women Warriors: A History
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