Coronavirus spread prompts FDA to postpone nearly all overseas inspections.

Brief:

The Food and Drug Administration is postponing inspections of overseas manufacturing plants and facilities supplying drugs to the U.S. except for those deemed "mission critical." The decision was based on travel restrictions and advisories put in place by the federal government in response to the global spread of the new coronavirus.

"Alternative tools and methods" will be used to maintain oversight of foreign manufacturers and products, the FDA said in Tuesday statement. The regulator acknowledged the move could affect its reviews of experimental drugs, however. For now, inspections will be postponed through April, though the FDA says it will resume inspections “as soon as feasible.”

Brief:

The Food and Drug Administration is postponing inspections of overseas manufacturing plants and facilities supplying drugs to the U.S. except for those deemed "mission critical." The decision was based on travel restrictions and advisories put in place by the federal government in response to the global spread of the new coronavirus."Alternative tools and methods" will be used to maintain oversight of foreign manufacturers and products, the FDA said in Tuesday statement. The regulator acknowledged the move could affect its reviews of experimental drugs, however. For now, inspections will be postponed through April, though the FDA says it will resume inspections “as soon as feasible.”

By Jonathan Gardner March 10, 2020 Published https://www.biopharmadive.com/news/FDA-postpone-foreign-drug-inspection-coronavirus/573859/