Extrapolation of indications in new drug approvals by the US Food and Drug Administration (FDA) to populations not originally studied in pivotal clinical trials is a common occurrence, according to a ...

A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices are safe for use in ...

CN Bio, a leading provider of Organ-on-a-chip (OOC) systems and solutions that accelerate drug discovery and development workflows, has introduced two new animal microphysiological system (MPS) models ...