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FDA Issues Good Machine Learning Practice Guiding Principles

USA - October 29 2021 FDA also solicited feedback from stakeholders on GMLP in its 2019 Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine…

Anisa Mohanty, Vernessa T. Pollard

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…

James W. Kim, Tony Maida, Brian J. Malkin, Vernessa T. Pollard

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…

Brian J. Malkin, Anisa Mohanty, Vernessa T. Pollard

The Toughest Problem Set: Navigating Regulatory and Operational Challenges on University Campuses

USA - August 27 2020 When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall…

Jennifer S. Geetter

The Toughest Problem Set: Navigating Regulatory and Operational Challenges on University Campuses

USA - August 26 2020 When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall…

Jennifer S. Geetter