FDA to Postpone Most Foreign Inspections Through April
The U.S. Food and Drug Administration is postponing most foreign inspections through April due to the coronavirus outbreak and will rely on measures such as product sampling at borders to ensure safety of imported products.
The FDA plans to mitigate any potential impacts, including on medical product application reviews, and will resume inspections as soon as feasible. (reut.rs/2IBvbi4)
More than 116,100 people have been infected by the virus globally and 4,090 have died due to the outbreak that began in Wuhan at the end of last year.
Infections outside China have been reported in 113 countries, resulting in the U.S. State Department prohibiting travel for U.S. government employees.
Other measures to ensure safety of imported products include physical examinations, checking records in place of on-site inspections and reviewing prior compliance history of firms.
The latest announcement adds to the FDA decision to postpone inspections of manufacturing facilities in China, earlier during the outbreak.
The health regulator previously said its ability to monitor the safety of products has not been affected. Inspections deemed critical by the U.S. would still be considered on a case-by-case basis, the FDA said.