Nano-medicine is the fastest growing field in pharmaceutical industry today. However, there still exist several hurdles preceding its clinical translation. This review provides insights on the guidelines for nanomaterials provided by the US-FDA (United States Food and Drug Administration), various approval pathways and also addresses the lacunae between academic research, pharmaceutical industry and US-FDA through an attempt to overcome the hurdle to its clinical translation. We have also emphasized various ways to overcome the described barriers which will provide the readers a brief understanding over the critical aspects where the scope of the guidelines may need to be revisited in order to exhibit their successful clinical translation from academic research to commercial feasibility.
Keywords: Clinical translation; convergence; harmonization; nanomaterials; regulatory aspects.