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Tuesday, 21 September 2021

FDA issues guidance for conducting clinical trials amid COVID-19 threat

Doaa A.Moneim , Wednesday 18 Mar 2020
Jessica Mendoza (C), Virginia Hospital Center outpatient lab specialist, and James Meenan (R), director of Virginia Hospital Center outpatient lab, make final preparations before opening a drive-through coronavirus testing site on March 18, 2020 in Arlington, Virginia. (AFP)

The US Food and Drug Administration issued on Wednesday a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.

According to a statement, the FDA recognised that the COVID-19 pandemic may impact the conduct of clinical trials for medical products, including drugs, devices and biological products.

“Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19,” the FDA said in the statement.

“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and assess how to move forward with critical clinical trials,” said Anand Shah, the FDA Deputy Commissioner for Medical and Scientific Affairs.

He added that the FDA released the guidance to emphasise that patients’ safety should continue to be at the forefront of considerations at all times.

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