FDA publish guidance on bioequivalence studies that have been impacted by COVID-19

Acknowledging the disruption to bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs) caused by the COVID-19 pandemic, the US Food and Drug Administration (FDA) has provided details on how sponsors should manage the situation.

The FDA emphasises the importance of protecting participants in bioequivalence studies. This has led the FDA to issue a separate guidance document on doing so during the COVID-19 public health emergency.

For prospective ANDA applicants, the FDA notes the inevitability of questions regarding protocol revisions and information collection. It details several further guidance documents on ways to resolve these issues:

Additionally, applicants wishing to ask general questions related to the impact of COVID-19 on bioequivalence studies, or notify the FDA of any bioequivalence studies that have been interrupted, can do so by contacting the agency via genericdrugs@fda.hhs.gov.

To view the guidance in full, click here.