Japan’s generic drug regulatory framework presents various challenges and requirements. To bring a generic drug to market, an Abbreviated New Drug Application (ANDA), proving the drug’s bioequivalence to the brand-name reference drug, must be submitted to the Pharmaceuticals and Medical Devices Agency (PMDA). Bioequivalence studies, quality control measures and potential clinical trials are all part of the vetting process. Recently, Japan has moved toward accepting foreign clinical data, easing the need for additional in-country trials.
GitHub Abused in New North Korea LNK Malware Campaign – SQ Magazine
GitHub Abused in New North Korea LNK Malware Campaign SQ Magazine
