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Center for Drug Evaluation and Research (CDER) Research and Development

Amundsen Davis LLC

FDA Issues First Ever Guidance for Research of Psychedelics

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Earlier this summer, the Food & Drug Administration (FDA) issued draft guidance for those researching the use of psychedelics to treat certain serious medical conditions including major depressive disorder, PTSD, and...more

MoFo Life Sciences

The Legal And Regulatory Landscape Evolving With AI In Life Sciences

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In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

TransPerfect Legal

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

TransPerfect Legal on

In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

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On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

MoFo Life Sciences

FDA Publishes Digital Health Technology Framework

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On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...more

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