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McDermott Will & Emery

FDA teases faster approval times with new agency-wide AI tool

McDermott Will & Emery on

The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more

Bass, Berry & Sims PLC

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

Bass, Berry & Sims PLC on

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

Hogan Lovells

"Make in India" Initiative Extends to Medical Devices - India's New Medical Device Rules Are Now in Effect

Hogan Lovells on

In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon implementation, this regulation replaced...more

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