[The role of the Food and Drug Administration as times change].

The prestigious journal Biostatistics published in July 2017 six solicited commentaries on the role of the U.S. Food and Drug Administration (FDA), as times change, with ever developing technical tools for clinical trials and their evaluation, with increased focus on personalised medicine (possibly aided by genetic testing), and on patient self-determination. Two were written by American economists, four by leading biostatisticians, mostly from the USA. This paper summarises these texts for a Danish audience.