FDA halts overseas inspections over coronavirus concerns

pharmafile | March 11, 2020 | News story | Research and Development, Sales and Marketing FDA, US, approvals, pharma 

The FDA has responded to the ongoing COVID-19 coronavirus outbreak by announcing that it will halt all inspections of overseas facilities until further notice.

“After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the US deemed mission-critical will still be considered on a case-by-case basis,” the agency announced via a release on its website.

The FDA said it considered a range of factors when making the decision, including travel recommendations coming out of the Centers for Disease Control and Prevention, guidance from the Office of Personnel Management, and the State Department Level 4 advice ruling out travel for employees of the US Government.

It also offered the assurance that it was considerate of how the decision will impact other FDA operations such as regulatory reviews, but it was confident in its ability to use alternative methods to maintain its oversight in sync with the federal government.

To this end, the FDA said it would employ previously successful strategies such as physical sampling of products at the border as well as reviewing compliance history of manufacturers and supplementary data from foreign governments, potentially denying the import of suspected non-compliant products.

The agency said it aims to recommence these foreign inspections as soon as it becomes feasible to do so.

Matt Fellows

Related Content

FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug …

GSK’s Ojjaara approved by FDA for patients with myelofibrosis and anaemia

GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) …

Madrigal Pharmaceuticals’ NDA for resmetirom accepted by FDA

Madrigal Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted for …

Latest content