Recognizing the impact the COVID-19 pandemic may have on the conduct of bioequivalence studies to support generic drug applications, the FDA advised sponsors of abbreviated new drug applications to prioritize the protection of the study participants as they consider restarting disrupted studies. General questions related to the impact of COVID-19 on bioequivalence studies and notification of interrupted studies should be directed to For studies that have yet to start, “potential applicants should submit specific questions related to their impacted bioequivalence studies, including questions about protocol revisions and information collection, via the controlled correspondence process,” according to the FDA.

The U.S. Patent and Trademark Office is further extending the deadlines for filing some patent documents and to pay certain required fees to June 1, 2020. Under a previous extension, they were due between March 27 and May 31.

No Comments