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Gugan Kaur advises life sciences clients on Food and Drug Administration (FDA) regulatory, compliance and enforcement issues. She provides counsel on matters throughout the product development process, including clinical trials, labeling and advertising, post-marketing, FDA inspections, and compliance and enforcement actions. She also advises clients on potential Federal Trade Commission (FTC) issues related to FDA-regulated products. Gugan has experience assisting clients in submitting trade complaints to FDA, FTC, the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP). Read Gugan Kaur's full bio.
By Vernessa T. Pollard, Anisa Mohanty and Gugan Kaur on Jan 20, 2021
Posted In Big Data
On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD: Further develop the proposed regulatory framework, including through draft guidance on a...
By Michael W. Ryan, Gugan Kaur, Anisa Mohanty and Vernessa T. Pollard on Oct 4, 2019
Posted In General Interest, Mobile Apps
The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical...