The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform clinical trial design. FDA also issued important rulemakings and guidance documents throughout 2016, although the agency’s publication of regulations and guidance documents increased after the enactment of the law. In the final days of 2016, FDA issued guidance to explain its interpretation of certain Cures Act provisions and to stake out legal positions before the start of the Trump administration.

This Special Report highlights notable FDA regulations, guidance and enforcement actions in 2016, as well as select developments in product promotion and communication of health care economic information to payors that occurred prior to the start of the Trump administration on January 20, 2017.