USA – FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19

The US Food and Drug Administration (FDA) on Tuesday gave advice to generic drugmakers on handling disruptions to bioequivalence studies needed to support abbreviated new drug application (ANDA) approval as a result of the coronavirus disease (COVID-19) pandemic.

On top of the massive health and economic toll caused by the outbreak, clinical trials have been particularly hard hit as dozens of drugmakers have halted or delayed studies and as they grapple with the impact of the virus and social distancing measures. Similarly, multiple clinical research organizations have said a large number of their trial sites have been impacted by the pandemic.
For bioequivalence studies, FDA says that “Challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference listed drug product, or other considerations if site personnel or study subjects become infected with COVID-19.”

FDA also points out that interruptions to bioequivalence studies could require protocol changes and disrupt the collection of information from studies…