Update on FDA’s Actions in Response to Coronavirus Disease 2019

FDA is an active partner in the coronavirus disease (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, and with our international counterparts. Here's what's new since our last MCMi email update on February 19, 2020.

FDA steps to ensure quality of foreign products

FDA continues to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity. (February 24, 2020)

Read the FDA statement

Supply Chain Update

FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage. (February 27, 2020)

Read the FDA statement

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