Search results
Results from the WOW.Com Content Network
Aggregate reporting, also known as periodic reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports.
Based on an evaluation of the potential safety concern, The FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
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, the program had received more than 40,000 adverse event reports. [1]
VigiBase is a World Health Organization's (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO's international drug monitoring programme. It is the single largest drug safety data repository in the world.
RADAR is led by Dennis West. Though it was without funding for its first four years, RADAR has raised about $12 million through grants from the National Institutes of Health, the American Cancer Society and other such institutions. Its work has identified safety problems with 33 drugs. Adverse drug events are a serious health problem.
(Reuters) - The U.S. FDA is ramping up its investigation of the clinical trials that tested an MDMA-based therapy, the Wall Street Journal reported on Friday, citing people familiar with the matter.
Another drug company, Amgen, has taken yet another approach, blocking GIP instead of activating it, as tirzepatide does; its drug, dubbed MariTide, produced about 20% weight loss, on average, over ...
A new report by the Clean Label Project has found that protein powders may contain something other than muscle-building nutrients: lead and cadmium, both of which are toxic.. The national ...