Covid-19 could affect FDA review times

During this public health emergency, The Food and Drug Administration (FDA) continues to execute and review activities whilst responding to the public health needs of the current Covid-19 pandemic.

The U.S. FDA’s User Fee programmes help the FDA to fulfil its mission to protect public health, whilst also helping to accelerate innovation in industry, and bring new treatment options to the American public.

The FDA has issued a statement, stating that the organisation will continue to perform user fee review activities, and application review teams across the agency will remain focused on their work as the FDA does “everything possible to maintain continuity of operations in a very dynamic situation.”

The organisation will be focusing on ways to use technology, in order to minimise the impact on any applications which are under review during this time. Additionally, the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) will continue to meet Medical Device User Fee Amendments (MDUFA) review goals. The FDA says it has, “taken steps to contact industry stakeholders to convert each previously scheduled meeting through May to a teleconference.”

In terms of marketing applications which have been put on hold, the FDA are “further extending response due dates by 90 days for Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests.”

The FDA warns that by extending the approval time, it is likely there will be a knock-on effect on the FDA and industry’s ability to meet the shared outcome goals for total time to decision as listed in the MDUFA IV commitment letter. Additionally, many staff in CDRH are currently focusing on Covid-19 activities related to pre-Emergency Use Authorisations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents. Therefore, the organisation warns, “it is possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.”

The statement concludes: “As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and as transparent as possible as we work to address the Covid-19 pandemic, as well as keep other key mission-critical initiatives unrelated to the pandemic moving forward.”