As of 15 June 2010, the new Food and Drug Administration (FDA) Postmarketing Drug Safety Evaluation website was launched. The FDA posted postmarket safety evaluations for 26 drugs approved between September 2007 and January 2008 and is reviewing an additional 20 or...
On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. ivermectin...
The Food and Drug Administration (FDA) is responsible for ensuring the safety of prescription drugs. Though all drugs are tested in clinical trials before they are available to the public, the risks of some drugs may not appear until well after they are approved. ...
On 15 July 2010 the European Medicines Agency (EMA) launched a new comprehensive website to address the regulation and safety of drugs (human, veterinary, and herbal) in the European Union. The site has been completely redesigned to optimize usability for the...
Although the Food and Drug Administration (FDA) routinely reviews the safety and effectiveness of all prescription drugs prior to approval, some side effects become evident only after the drugs are taken by millions of patients – far more than it is possible to...
The recent approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) of the 7 protein biomarker panel for use in detecting drug-induced kidney damage means that the biomarkers are now qualified at the same level by all of the ICH regulatory agencies....
