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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more
We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift marks the end...more
We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more
The health care industry is increasingly adopting mobile apps for a variety of purposes, including tracking patient health conditions and sharing patient data. Privacy and security are important considerations, and it is...more
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more