FDA Year in Review: A Shifting Regulatory Landscape

FDA Year in Review: A Shifting Regulatory Landscape

January 15, 2020

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.…

FDA Year in Review: A Shifting Regulatory Landscape

January 7, 2020

FDA Issues Warning Letters to 15 Companies, Consumer Update on CBD Safety

By Allison Fulton & Christopher Van Gundy

December 10, 2019

On November 25, 2019, FDA issued Warning Letters to 15 companies illegally marketing cannabidiol (CBD) products. On the same day, U.S. Food & Drug Administration (FDA) published a revised consumer update, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” describing the “very limited” scientific information available about CBD and its health effects. The points made in the Warning Letters and…

Cannabis Law Blog

FDA Issues Warning Letters to 15 Companies, Consumer Update on CBD Safety

By Allison Fulton & Christopher Van Gundy

November 26, 2019

Adapting To FDA’s Proposal For Diagnosis Support Software

November 11, 2019

*This article was originally posted in Law360 on November 4, 2019 With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options.…

Adapting To FDA’s Proposal For Diagnosis Support Software

November 8, 2019

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

By Allison Fulton & Sarah Blitz

September 30, 2019

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to…

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

By Allison Fulton & Sarah Blitz

September 30, 2019

Tips for When to Consider Legal Review of Quality System Investigations

September 23, 2019

This post was originally published on MD+DI.com. As a lawyer with extensive experience in good manufacturing practice (GMP) issues, clients will ask me to review complex Quality System investigations. My clients are typically in-house counsel and, while review by Legal makes sense to a company’s in-house counsel (after all they, too, are lawyers), Quality or Manufacturing personnel often are flummoxed.…

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence