FDA Guidance “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”

On January 15, 2021, FDA published a new guidance for industry, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency. FDA is issuing this guidance to assist prospective applicants of abbreviated new drug applications (ANDAs) in ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted to support the approval of an ANDA that have been disrupted during the COVID-19 public health emergency.

FDA recognizes that the COVID-19 public health emergency may impact the conduct of BE studies to support demonstration of BE and approval of an ANDA. Public health measures to control the virus have posed challenges to conducting these BE studies 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. 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 (GCP), which this guidance encourages.

The current public health emergency necessitates the consideration of minimizing risk of exposure to SARS-CoV-2. The guidance includes recommendations on ensuring the safety of participants throughout the study process, Standard Operating Procedure (SOP) development, protecting scientific validity, and planning for timely and organized resumption of BE studies.

The FDA is issuing this guidance to facilitate the safe conduct of BE studies during the COVID-19 public health emergency. The ongoing development of generic drugs submitted as ANDAs to the FDA for assessment helps Americans continue to have access to safe, effective generic drugs. For full details, please view the guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/protecting-participants-bioequivalence-studies-abbreviated-new-drug-applications-during-covid-19.

OGD 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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