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It is increasingly important for mobile app developers to ensure their products comply with all governing state and federal laws, and it is critical to understand which business changes might place your product under a...more
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more