Day: March 26, 2020

The Indian government took several measures to protect its population from COVID-19, among them a ban of export of any products needed to manage the pandemic such as masks, PPE, ventilators, and chloroquine. The export ban for selected items by the Indian government is designed to prevent price gauging and to assure that sufficient supplies … Read more

This week Gilead’s decision to ask FDA to rescind its orphan drug designation for its COVID-19 drug highlighted the loophole in the overall rules for orphan drug designations. Unlike all other expedited approval designations, orphan drugs designations (ODD), once granted by the FDA cannot be rescinded by the FDA, under almost all circumstances. Gilead reportedly … Read more