Drugs

Guidance on Bioequivalence Studies During Covid Emergency

FDA has made available a new guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the Covid-19 Public Health Emergency. The document is intended to assist prospective ANDA applicants in ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted to support an ANDA approval that have been disrupted during the Covid-19 public health emergency.

The guidance recommends that applicants consider the potential impact of participation on the participants’ health (e.g., the diagnoses of participants in BE studies, comorbidities, etc.) in any particular study. “Additionally, we recommend that the safety of study site staff be protected, and care taken to ensure study integrity and scientific validity of the data generated due to modifications to study conduct or design,” it says. “Accordingly, we recommend that sites develop site-specific plans for the resumption or initiation, as appropriate, of safe, timely, and organized BE studies.”

ANDA applicants must provide adequate information in 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 based on recommendations from FDA, the guidance says. It adds that the Office of Generic Drugs will determine acceptability of a BE study supporting am application during the scientific assessment of an ANDA.

Because of Covid-19, the agency says it is important to developing additional recommendations for procedures “to ensure the safety of the healthy participants who are enrolled in studies to support ANDAs as well as the safety of participants in the patient population for which the reference product is indicated for the subset of BE programs in which a healthy population is not indicated. Resumption and initiation of BE studies should follow applicable (national or local) guidelines and requirements to control the spread of the virus.”

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