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
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
