FDA Year in Review: A Shifting Regulatory Landscape

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. Continue Reading

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

By Allison Fulton and Christopher Van Gundy on December 10, 2019 Posted in Cannabis

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 update are nothing new to those closely following the FDA working group on cannabis and CBD, but the actions signal the FDA’s continued enforcement against companies marketing CBD foods, supplements, and cosmetics with unsupported health claims. Continue Reading

Adapting To FDA’s Proposal For Diagnosis Support Software

By Allison Fulton on November 8, 2019 Posted in Digital Health & Medical Devices

*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. Continue Reading

BREAKING NEWS: USDA Releases Interim Final Hemp Rule

By Sarah Blitz on October 30, 2019 Posted in Cannabis

On October 29, 2019, the U.S. Department of Agriculture (USDA) released its long-awaited interim final rule governing the U.S. Domestic Hemp Production Program. USDA has been developing these interim regulations since hemp was federally legalized under the 2018 Farm Bill. These hotly anticipated rules are important not only for hemp producers and hemp-derived product companies, but for cannabis companies interested in diversifying or pivoting into a crop that is legal under federal law. Continue Reading

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

By Allison Fulton and Sarah Blitz on September 30, 2019 Posted in Digital Health & Medical Devices

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 inform their regulatory strategies. Continue Reading

Tips for When to Consider Legal Review of Quality System Investigations

By Allison Fulton on September 23, 2019 Posted in FDA

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. Continue Reading

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

By Allison Fulton on September 20, 2019 Posted in Digital Health & Medical Devices

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway. Continue Reading

How FDA Considerations Impact Food and Beverage Acquisitions

By Allison Fulton, Ariel Yehezkel and Allison Wu Troianos on August 15, 2019 Posted in Food & Dietary Supplements

This post was originally published on FoodDive.com.

When considering an acquisition of a food and beverage company, potential buyers of a company or its assets should pay particular attention to U.S. Food and Drug Administration requirements and their implications on the target’s business.

Buyers should be cognizant of the regulatory issues at the beginning of the process so that their risk can be assessed in the context of the transaction, and in turn, be addressed by specific representations, covenants and indemnification provisions in the transaction documents. The following considerations should be top of mind throughout the course of due diligence and negotiations. Continue Reading

What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution

By Samuel Gilkeson and John Tilton on July 26, 2019 Posted in FDA

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States. Continue Reading

Regulating E-Cigarettes Remains “Top Priority” For FDA

By Allison Fulton on July 12, 2019 Posted in Tobacco

On July 10, 2019 Ned Sharpless, M.D., the Acting Commissioner of the Food and Drug Administration (FDA) issued a statement reaffirming FDA’s commitment to overseeing the manufacturing, marketing, and sale of e-cigarettes. The statement outlined FDA’s current and anticipated regulation of e-cigarettes, and discussed the balance of keeping e-cigarettes out of the hands of minors while exploring the potential for e-cigarettes to reduce adult smoking of more harmful tobacco products. Continue Reading

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