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FDA Year in Review: A Shifting Regulatory Landscape

USA - January 7 2020 The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and...

FDA Issues Warning Letters to 15 Companies, Consumer Update on CBD Safety

USA - November 26 2019 On November 25, 2019, FDA issued Warning Letters to 15 companies illegally marketing cannabidiol (CBD) products. On the same day, U.S. Food & Drug...

Christopher Van Gundy.

Adapting To FDA’s Proposal For Diagnosis Support Software

USA - November 8 2019 This article was originally posted in Law360 on November 4, 2019 With the rise of artificial intelligence and machine learning, clinical decision...

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

USA - September 30 2019 On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement...

Sarah Blitz.

Tips for When to Consider Legal Review of Quality System Investigations

USA - September 23 2019 As a lawyer with extensive experience in good manufacturing practice (GMP) issues, clients will ask...