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The FDA has published guidance on COVID-19 considerations for BE studies(Source:Shutterstock)

Guidance on protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 pandemic has been published by the US Food and Drug Administration.

In the final guidance, the FDA recognizes that the coronavirus pandemic “may impact the conduct of BE studies in human participants to support demonstration of BE and approval of an ANDA,” pointing in particular to the challenges of 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,” the FDA observes. “These BE studies may have been suspended at various stages ranging from protocol development, recruitment, screening, during a study period, or in between study periods.”

“The unexpected disruptions of BE studies have compelled the clinical research industry to find short-term alternative measures while identifying sustainable and feasible long-term solutions,” the agency said. Moreover, the FDA also acknowledged “the resulting challenges that the generic pharmaceutical industry faces due to the COVID-19 public health emergency and its control measures across the globe.”

The US agency summarized that “for BE studies with human participants, protecting participant rights, welfare and assuring the quality and integrity of the data while maintaining compliance with all applicable regulatory requirements continue to be the main focus.” In addition, it said, the current pandemic “necessitates the consideration of reducing risk of exposure to SARS-CoV-2.”

In the guidance, the FDA lays out inclusion and exclusion criteria, as well as models and study designs that can mitigate the risk of COVID-19 to ensure the safety of participants throughout the study process. It covers standard operating procedure development, protecting scientific validity, and planning for the “timely and organized” resumption of BE studies.

Good Documentation Practice For Protocol Deviations Is Key

Emphasizing the importance of protecting the scientific validity of BE studies, the FDA acknowledged that the COVID-19 pandemic “has led to various deviations and other challenges. For example, contingency measures may have been necessitated by government-level measures to control the virus and additional actions to maintain safety and public health may have been implemented prior to approval of protocol modifications, thereby leading to unavoidable protocol deviations.”

In this context, the agency advised that “good documentation practice for protocol deviations plays a key role.”

“This situation underscores the importance of balancing the protection of participant rights, welfare, and the assurance of the quality and integrity of the data while maintaining compliance with good clinical practice,” the FDA commented, “which this guidance encourages.”

The agency also emphasized that its Office of Generic Drugs “encourages current and prospective applicants to submit controlled correspondence with any inquiries about restarting BE studies or about using adaptive study designs if study modifications are needed.”

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