Startup? Organized in Delaware? Then you likely received a notice from the Secretary of State of Delaware saying you owe thousands (maybe even tens of thousands) in franchise taxes and have to file an Annual Report by March 1, 2020. DON’T PANIC!! There are two ways to calculate franchise taxes, and Delaware defaults to the
In a long-anticipated move, the United States Food and Drug Administration (FDA), on September 26, 2019, published six guidance documents clarifying its scope of authority and enforcement discretion policies with regards to Digital Health Content in light of the questions raised by the 21st Century Cures Act (Cures Act).
In this article, we take a look at the FDA’s draft guidance that proposes a framework of regulating Clinical Decision Support (CDS) Software, including software containing machine-learning algorithms (ML).…
Continue Reading FDA Guidance Clarifies Clinical Decision Support, Machine-Learning, and Other Digital Health Content