Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties.
Scientists and entrepreneurs who contemplate developing nanomedicine products face several unique challenges in addition to many of the traditional hurdles of product development. In this review we analyze the major physicochemical, biologic and functional characteristics of several nanomedicine products on the market and explore the question of what made them unique. What made them successful? We also focus on the regulatory challenges faced by nanomedicine product developers. Based on these analyses, we propose the factors that are most likely to contribute to the success of nanomedicine products.
Nijhara
Ruchika
R
University of Maryland, Office of Research and Development, Baltimore, MD, USA.
Balakrishnan
Krishna
K
D000818:Animals; D004337:Drug Carriers; D006801:Humans; D008389:Marketing of Health Services / Q000639:trends; D050997:Nanomedicine / Q000191:economics* / Q000331:legislation & jurisprudence* / Q000592:standards / Q000639:trends; D035501:Uncertainty; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D004337:Drug Carriers