ABSTRACT

Keywords: nanotechnology, nanopharmaceutical, nanomedicine, parenteral delivery, oral delivery, dermal and transdermal delivery, pulmonary delivery, US Food and Drug Administration, patent, liposomes, microemulsions, polymeric micelles, theragnostics, NanoCrystal® technology, Abbreviated New Drug Application, US Patent & Trademark Office, commercialization, PEGylation, colloid, nanoparticles, bioequivalent 9.1 Introduction

9.1.1 Nanotechnology and NanomedicineNanotechnology and nanomedicine, the high-risk, high-payoff global phenomenon, is in full swing. Advances in these areas are driven by collaborative research, patenting, commercialization, business

development, and technology transfer within diverse areas such as chemical engineering, biomedicine, physical sciences, and informa-tion technology [1-3]. The confusion and ambiguity surrounding the definition

of nanotechnology continues to be one of the most significant problems shared by regulators, policy-makers, researchers, and legal professionals alike. Various companies, universities and individuals have thrown around the “nano” prefix to suit their limited purpose, whether it is for research funding, patent approval, raising venture capital or seeking publication in a journal.