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US FDA discloses actions being taken in response to coronavirus outbreak

The U.S. Food and Drug Administration is working closely with government and public health partners across the U.S. Department of Health and Human Services, as well as with international counterparts, to diagnose, treat and prevent the novel coronavirus disease.

In a Feb. 14 news release, the regulator said the coronavirus outbreak is likely to impact the medical product supply chain. Risks include shortfall of critical products in the U.S., as raw materials used in manufacturing are sourced from China and other locations in Southeast Asia.

The FDA said it is monitoring the medical-product supply chain for potential shortages or disruptions and is providing assistance to mitigate such impacts. This includes closely working with manufacturers and expediting a review for an alternate supply to prevent shortages.

The FDA is also maintaining contact with manufacturers of drugs and medical devices as well as global regulators such as the European Medicines Agency to monitor the situation for early warning signs of manufacturing discontinuances or interruptions due to the outbreak.

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Safety and security of the medical-product supply chain remains one of the FDA's top priorities, the agency stated.

The FDA said it is currently conducting normal inspections except in China because of the State Department's travel warning. The U.S. regulator usually conducts about 500 inspections each year in China and has postponed all scheduled inspections in the country for the month of February.

Any travel to China that is deemed mission-critical is being assessed on a case-by-case basis in close coordination with the U.S. Department of Health and Human Services and the State Department.

The agency said surveillance testing of all imported products continues and products from China must comply with the same standards as domestic products.

The FDA has not determined any additional measures to review products from China as there is no evidence to support the transmission of COVID-19, the disease caused by the novel coronavirus, with imported goods.

In addition, the regulator has established a cross-agency taskforce to monitor fraudulent products and false product claims related to COVID-19.

The FDA authorized the emergency use of a test developed by the Centers for Disease Control and Prevention to detect the coronavirus.

The coronavirus has infected more than 64,000 people and caused over 1,300 deaths, mostly in China, according to a tracker from Johns Hopkins University's Center for Systems and Science and Engineering.