FDA issues guidance for resuming or initiate BE studies during Coronavirus (COVID–19)

Article summary

The US Food and Drug Administration (FDA) has issued guidance for participants who may resume or initiate bioequivalence (BE) studies during the coronavirus (COVID–19) pandemic. The guidance provides recommendations for drug developers to cautiously practice the protocols for BE studies, ‘pandemic-tailored inclusion and exclusion criteria’, and to ensure the data generated from the studies ensures scientific validity. The FDA recognises the impact coronavirus has on conducting ‘BE studies in human participants to support demonstration of BE and approval of Abbreviated New Drug Applications (ANDA)’. Conducting BE studies are limited at present due to study site and laboratory closures, as well as travel limitations. Therefore, the practice on human participants may be suspended. The FDA recommends that study sites should develop or revise ‘standard operating procedures (SOPs)’ to reduce the risk of transmission of the virus towards participants and study staff.