“…Without clear and specific regulatory guidelines supporting nanomedicine development, strategic financial investments cannot be properly weighed, which may result in slow development of nanomedicines. ,, Conventional drug development programs are time-consuming and expensive, taking ∼5–12 years (out of a 20 year patent) and costing >350 million USD (not including marketing costs and liabilities) to produce a single product for a specific application under one regulatory agency . As nanomedicines are physically complex, likely subject to inconsistent regulations, and can require alternative testing methods for evaluation, the time and cost for their development may be significantly higher . Additionally, while phase I trials for nanomedicine are often promising (>90% successful), the success rate of phase II and III trials, which measure safety and efficacy, is only at 48% and 14%, respectively .…”