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Life Sciences Webinar: Key Enforcement & Compliance Issues Impacting Your Business

USA - June 17 2021 One of the few constants in the evolving government enforcement landscape is a focus on life sciences companies and their interactions and financial…

Dana McSherry, David S. Rosenbloom, Tony Maida.

FDA Issues Artificial Intelligence/Machine Learning Action Plan

USA - January 20 2021 On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a…

Anisa Mohanty, Gugan Kaur.

FDA 2020 Year in Review

USA - January 14 2021 The US Food and Drug Administration (FDA) became a central focus of the nation and world’s attention in 2020, since the agency regulates many of the…

Brian J. Malkin, James W. Kim, Michael W. Ryan, Tony Maida.

Special Fraud Alert: OIG Raises Concerns with Speaker Programs

USA - November 17 2020 In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker…

James A. Cannatti III, Joan Polacheck, Monica Wallace, Nicholas Francis Alarif, Tony Maida.

FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule

USA - September 25 2020 On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to…

Anisa Mohanty, Brian J. Malkin, Michael W. Ryan.