FDA issues guidance on resuming or initiating BE studies amid pandemic

Regulatory NewsRegulatory News | 15 January 2021 |  By 

New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.
The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by the pandemic.
“FDA recognizes that the COVID-19 public health emergency may impact the conduct of BE studies in human participants to support demonstration of BE and approval of an [abbreviated new drug application] ANDA. Public health measures to control the virus have posed challenges to conducting BE studies generally due to 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,” FDA writes.
The agency notes that ANDA applicants “must provide adequate information in their submissions related to any disruption in their BE studies or deviation from study protocols associated with the COVID-19 public health emergency, even when such deviations are made in connection with recommendations from FDA.”
The guidance provides specific recommendations aimed at protecting BE study participants, including pandemic-tailored inclusion and exclusion criteria and the use of electronic or alternate informed consent methods to reduce participants’ potential exposure during study visits. The guidance also proposes two examples of infection mitigation models for study visits, one in which participants and possibly site staff are confined to a facility for the duration of the study and the other where participants come and go from the study site with additional measures for mitigating the risk of COVID-19 transmission.
Both approaches involve tradeoffs, FDA admits: “Example 1 may, however, result in the possibility of infection being transmitted within the facility and may subject staff to sequestration or screening upon entrance to and exit from the study environment … Example 2 may, however, result in increased risk of infection from sources external to the site.”
FDA also offers four approaches to participant sampling that could reduce risk to participants: alternative pharmacokinetic (PK) modeling to optimize sampling time points, spaced dosing and sampling, off-site sampling and eliminating nonessential in-person follow-up visits.
Before resuming or initiating BE studies, FDA recommends that study sites develop or revise standard operating procedures (SOPs) to “mitigate risks of exposure to the virus as well as protect participants and study staff while maintaining study integrity.”
Additionally, FDA makes recommendations for ensuring the scientific validity of BE studies, addressing protocol amendment and development, deviations, study oversight and drug expirations.


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