Scientific Publications by FDA Staff

Regul Toxicol Pharmacol 2019 Aug;106:187-96

Bridging communities in the field of nanomedicine.

Halamoda-Kenzaoui B, Baconnier S, Bastogne T, Bazile D, Boisseau P, Borchard G, Borgos SE, Calzolai L, Cederbrant K, Di Felice G, Di Francesco T, Dobrovolskaia MA, Gaspar R, Gracia B, Hackley VA, Leyens L, Liptrott N, Park M, Patri A, Roebben G, Roesslein M, Thurmer R, Urban P, Zuang V, Bremer-Hoffmann S

An early dialogue between nanomedicine developers and regulatory authorities are of utmost importance to anticipate quality and safety requirements for these innovative health products. In order to stimulate interactions between the various communities involved in a translation of nanomedicines to clinical applications, the European Commission's Joint Research Centre hosted a workshop titled "Bridging communities in the Field of Nanomedicine" in Ispra/Italy on the 27th -28th September 2017. Experts from regulatory bodies, research institutions and industry came together to discuss the next generation of nanomedicines and their needs to obtain regulatory approval. The workshop participants came up with recommendations highlighting methodological gaps that should be addressed in ongoing Horizon 2020 projects addressing the regulatory science of nanomedicines. In addition, individual opinions of experts relevant to progress of the regulatory science in the field of nanomedicine were summarised in the format of a survey.