Archive for June, 2021


Promotion of Devices Subject to the FDA’s COVID-19 Enforcement Policies

The Biden Administration’s withdrawal of the Trump Administration’s proposal to exempt 84 medical device types from the FDA’s premarket notification, or 510(k), requirement, underscores the promotional framework that developers and marketers of these devices are subject to.  The Trump Administration proposal included devices critical to combating the COVID-19 public health…

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SEC Chairman’s Comments Signal Likely Changes to Rule 10b5-1 Trading Plans

Rule 10b5-1 trading plans have faced increased scrutiny since the onset of the COVID-19 pandemic and the corresponding public focus on stock sales by executives of public life sciences companies. On June 7, 2021, SEC Chairman Gary Gensler continued that scrutiny when he delivered prepared remarks to the Wall Street…

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