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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.
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.
A total of 75 mice died in a research lab at the University of Notre Dame after research staff mistakenly doubled the dose of an experimental drug last fall, the university recently self-reported ...
The reports are created by the Best Buy Drugs team and an independent academic group, Research on Adverse Drug Events and Reports (RADAR), devoted to detecting drug safety issues. [6] The project also reports on drugs prescribed off-label to highlight common off-label uses, evaluates the clinical evidence and safety information for those uses ...
Drug companies use compounds classified as PFAS because they are very hard to degrade, Ruyle said. This can increase the concentration of drugs in people’s bodies.
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1]