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:
- “Adaptive Designs for Clinical Trials of Drugs and Biologics” details general scientific principles on adaptive designs but is not specific to bioequivalence studies in support of ANDAs.
- “Controlled Correspondence Related to Generic Drug Development” provides a comprehensive overview of when and how to liaise with the FDA in order to get clarity on a specific issue.
- “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA” details when it is appropriate to request a pre-ANDA meeting with the FDA and what to include in an application.
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 firstname.lastname@example.org.
To view the guidance in full, click here.