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....
Face it, the Food and Drug Administration’s (FDA) website is not the most user friendly of Regulatory options! For the incredibly low price of $30 USD you can now have a comprehensive superset of 4 CD‑ROMs which provide an up-to-date collection of documents, manuals,...
