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FDA Guidance for Clinical Trials During COVID-19 Pandemic

The FDA issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the novel coronavirus (COVID-19) pandemic.

Although the impact of COVID-19 on trials will vary based on many factors, including the nature of disease being studied, the trial design, and in what regions the study is being conducted, the FDA outlined considerations to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize the risks to trial integrity.

“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA, said in a press release. “The FDA released this guidance to emphasize that at all times, patients’…

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