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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011 ...
Reporting requirements and quantity limitations vary by state. [14] A Congressional report said that when an ephedra supplement company, Metabolife, in the USA was forced to release adverse event reports, cardiac and psychological reports were recorded in healthy young people at normal dosages. [15]
It authorizes the FDA to require a responsible person for a drug to conduct a post-approval study or clinical trial of the drug to assess a known serious risk or signals of a serious risk or to identify an unexpected serious risk, to require a postapproval study or clinical trial for an already approved drug only if the Secretary becomes aware ...
The most common treatment-emergent adverse events with Gattex in the placebo-controlled studies that occurred at a higher frequency with Gattex were abdominal pain, upper respiratory tract ...
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
Some research has noted that there is scarce safety information available to the public about dietary supplements on the market. [13] Other research has shown that the FDA has an insufficient network in the dietary supplement marketplace for responding to reports of adverse events. [14]
Over the period 2008 to 2011, the Government Accountability Office (GAO) of the United States received 6,307 reports of health problems (identified as adverse events) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products, [86] with 92% of tested herbal supplements ...