FDA

FDA takes additional steps to advance decentralized clinical trials

The U.S. Food and Drug Administration is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites....

02 May, 2023

FDA outlines plan for digital health technologies for clinical trials

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year....

24 March, 2023

Responding to FDA inspections in an era of closer scrutiny

Many changes were made to the FDA's requirements for clinical research during the pandemic, including adoption of decentralized clinical trial elements. How will this affect future inspections....

21 March, 2023

FDA

FDA takes additional steps to advance decentralized clinical trials

FDA outlines plan for digital health technologies for clinical trials

Responding to FDA inspections in an era of closer scrutiny

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