In the weeks since the virus first struck the country, the US Food and Drug Administration (FDA) has issued a number of safety alerts, guidances and other responses related to preventing the spread of the disease. Many of these have potential impact on pharmaceutical manufacturing, clinical trial operations and other industry concerns.
According to FDA commissioner Stephen Hahn, the agency and its partners are taking every effort to help the public, patients, healthcare professionals, and manufacturers.
“The FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with federal partners, international regulators and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak,” he added.
This week’s actions include an update on the agency’s recommendations regarding specimen collection for COVID-19 testing. According to the FDA, nasal swabs collected from symptomatic patients would just as effective collected from just the front of the nasal cavity than its depths; this would provide for greater ease, efficiency and comfort on sample collection.
The agency’s Oncology Center of Excellence also advised the medical community that cancer patients are potentially immunocompromised and therefore stand a greater risk of contracting the virus. Center leadership announced they are focused on addressing the critical needs of patients with cancer and their health care providers.
The FDA also provided information on issuance of emergency use authorization (EUA) for virus diagnostic tests. To date, the agency announced it has worked with more than 160 test developers with applications submitted to make COVID-19 diagnostic tests. So far, 15 EUAs have been issued. The FDA has been notified by more than 65 laboratories.
Last week, the FDA issued a guidance document featuring advice regarding operating clinical trials. The document outlines difficulties and concerns sites and sponsors likely are facing during the pandemic, including travel bans, quarantines, supply chain interruptions and other considerations.
Earlier in March, the agency took measures to help expedite development of diagnostic tests for COVID-19. The purpose of the test is to increase nationwide testing capacity and expedite development of such tests.
