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Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

Ropes & Gray LLP on

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Orrick, Herrington & Sutcliffe LLP

“Good” and “Safe” Data – Panel Launches Artificial Intelligence Initiative

On April 25, 2019 Orrick’s Successful Women in IP (SWIP) group and the newly launched AI Cross Practice Initiative joined forces to bring together industry-leading AI experts for a lively panel discussion on the data used to...more

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