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The Brazilian Health Regulatory Agency (Portuguese: Agência Nacional de Vigilância Sanitária, Anvisa, literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso's term of office.
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.
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
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.
By 2019, the FDA tallied 82 suicides linked to Singulair and its generic versions reported to its adverse-event database since 1998. At least 31 of those reports involved someone age 19 or younger.
Psychiatric adverse drug reactions, amnesia. [3] [66] Triparanol: 1962 France, US Cataracts, alopecia, ichthyosis. [3] Troglitazone (Rezulin) 2000 US, Germany Hepatotoxicity [2] Trovafloxacin (Trovan) 1999–2001 European Union, US Withdrawn because of risk of liver failure [2] [3] Valdecoxib (Bextra) 2004 US Risk of heart attack and stroke. [2 ...
A number of clients who received injections at the clinic in question, JGL Aesthetics, claimed to experience several adverse side effects, with at least one confirmed case of botulism, USA TODAY ...
Adverse event coding is the process by which information from an AE reporter, called the "verbatim", is coded using standardized terminology from a medical coding dictionary, such as MedDRA (the most commonly used medical coding dictionary). The purpose of medical coding is to convert adverse event information into terminology that can be ...