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In the Weeds — FDA Enforcement Priorities, Public Hearing, and Litigation Considerations for Cannabis Products

USA - April 5 2019 CBD, or cannabidiol, is a compound in the cannabis plant that does not cause the psychoactive or hallucinogenic effect of tetrahydrocannabinol (THC)…

Caitlin C. Blanche, Zachary W. Ernst

CMS Announces Artificial Intelligence Health Outcomes Challenge

USA - April 2 2019 On March 29, 2019, the Centers for Medicare & Medicaid Services (CMS), in partnership with the American Academy of Family Physicians (AAFP) and the…

Gina L. Bertolini, Corey Bieber, Jason R. Freeck

FDA Releases Guidance on How Recent Changes to the Common Rule May Impact FDA-Regulated Clinical Trials

USA - October 16 2018 On October 12, 2018, the U.S. Food and Drug Administration (“FDA”) released a guidance document titled “Impact of Certain Provisions of the Revised…

Kenneth M. Kennedy, David M. Parker, Steven G. Pine

Recent federal and state actions in support of proposition 65 exemption for coffee reinforces need for science-based nutrition information

USA - September 6 2018 The words “coffee” and “cancer” have been used in sentences together more over the past several years than the coffee industry ever could have…

Caitlin C. Blanche, Amanda Makki

In the Weeds: Navigating the Shifting Federal Regulation of Medical Marijuana

USA - July 13 2018 The federal government’s view of medical marijuana is evolving as the U.S. Food and Drug Administration (“FDA” or “Agency”), on June 25, 2018…

Varsha D. Gadani, Amanda Makki