The US FDA’s Center for Drug Evaluation and Research is coming off what in many lights could be the best year ever for new drugs – a record number of novel agents, reviewed in record low times, reflecting high levels of innovation and addressing many previously unmet needs – but the early weeks of 2019 suggest the beginning of different story, marked by resurgent safety concerns and the disruption of the regulatory system posed by the recent partial government shutdown.
Despite these headwinds, however, the pipeline of novel candidates for approval looks strong in the new year. The Pink Sheet’s FDA Performance Tracker identified almost 40 novel agent applications currently...