USA – FDA issues guidance on resuming or initiating BE studies amid pandemic

New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.

The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by the pandemic.

“FDA recognizes that the COVID-19 public health emergency may impact the conduct of BE studies in human participants to support demonstration of BE and approval of an [abbreviated new drug application] ANDA. Public health measures to control the virus have posed challenges to conducting BE studies generally due to travel limitations, study site closures, and laboratory closures. Consequently, BE studies in human participants may have been suspended, resulting in interruptions in the development of study products,” FDA writes…