AroCell announced today that the US Food and Drug Administration (FDA) has informed once again that the impact of the COVID-19 pandemic and the reallocations of staff is leading to an even greater prolonged timeline for reviews of submissions. FDA informed that the delay is prolonged with another 90 days and will prolong all submission review.
FDA’s Center for Devices and Radiological Health (CDRH) has been actively engaged in responding to the current pandemic caused by a novel coronavirus (SARS-CoV-2). They state that due to the sustained volume of EUA (Emergency Use Authorization) requests and continued importance of testing in the response to the pandemic, they are not yet able to resume the review of submissions.
AroCell will receive updates regarding the anticipated timeline for the resources on the non-COVID related activities.