Abstract

At any given time, the US Food and Drug Administration (FDA) can have dozens of ongoing pilot programmes involving single or multiple Centers. It can be challenging to track the existence and status of programmes, as well as what companies might be invited to participate, or what companies are asked to submit a request to participate. Pilot programmes are formally announced by the FDA via the Federal Register and press releases but, in today’s world of information overload, some can go unnoticed if they are not directly related to therapeutic or technical synergies within a sponsor company.  This article reviews four of the FDA’s more recent notable pilots, some of which are ongoing and some of which have been completed. The pilots each focus on a different topic: study data technology, guidance comprehension, rare diseases and medical devices.