Commercialization Note The nanomedicines alliance: an industry perspective on nanomedicines

The field of nanomedicines has expanded significantly in recent years in the breadth of compounds under development as well as in the types of technology that are being applied to generate nanomedicines. The pathway to licensure of new nanomedicines is sufficiently well defined by existing regulations and guidance. The future of nanomedicines requires collaboration between industry and regulatory agencies to ensure that safe and effective nanomedicines emerge from this field. From the Clinical Editor: With the expansion of translational nanomedicine research, the “last steps” of translation, such as making sure all regulatory approvals are met, the availability of appropriate larger-scale production technologies, are becoming critically important. This review provides a perspective from the biomedical and pharmaceutical industry on the above issues.