General – Page 3 – Duane Morris Life Sciences Law

August 10, 2023 by Duane Morris

Nitrosamine Impurities FDA Guidance

By Alan Klein, Patrick Gallagher and Michael Fox

On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.)

Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency’s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union’s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with “1” being the most potent, and “5” the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.

July 26, 2023July 28, 2023 by Duane Morris

Article in Business of Fashion Quotes Kelly Bonner

Duane Morris attorney Kelly A. Bonner was quoted in an article in The Business of Fashion titled “What Beauty Needs to Know About the Biggest New Regulations in 80 Years,” about the Modernization of Cosmetics Regulations Act (MoCRA) recently signed into law. To read the full text of this article, please visit the firm website.

July 11, 2023 by Duane Morris

Minor Procedural Updates to FDA Guidance on Q-Submissions

On June 2, 2023, the FDA issued its most recent guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The Q-Sub Program is used by the FDA to track the requests for feedback and interactions between the FDA and medical device companies prior to submitting for FDA approval. The 2023 guidance provides updated resources and tools for medical device companies, or submitters, looking to request feedback from the FDA during the development process of potential or planned medical devices.

Read the full Alert on the Duane Morris LLP website.

July 5, 2023 by Duane Morris

Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq.,
in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.

June 26, 2023 by Duane Morris

What Sunscreen Regulation Means for the Spa Industry

Kelly Bonner’s article for Well Spa 360 discusses recent sunscreen recalls, regulation and its impact on spa businesses.

“It’s hard to underestimate the importance of regularly wearing sunscreen to protect the skin from harmful ultraviolet rays. But recent reports suggest traces of benzene in sunscreens and a link to human health ailments have led to several voluntary recalls and consumer class litigation involving well-known brands. Concerns about whether certain sunscreens are actually “green,” “sustainable” or “reef-friendly” have left consumers in the dark about what those terms mean, while leaving brands vulnerable to consumer class action litigation.

“Here’s what spas need to know about the most recent controversies surrounding sunscreen.”

Read the full article at WellSpa360.com.

June 26, 2023 by Duane Morris

Outlook for Life Sciences M&A: Industry Drivers Still Strong

In a recent GEN Edge article, Duane Morris partner Rebecca Guzman discussed the state of M&A activity in the life sciences.

“Following the most robust year for life sciences M&A on record, the sector saw a sharp decline in 2022 to levels below what we last experienced pre-pandemic. Many analysts pointed to supply chain issues, clinical development delays and other lingering effects of the COVID-19 pandemic as the cause. The 2021 catalysts of innovation following the pandemic breakout had finally worn off. On the surface, it appeared that key industry players had taken a step back, or even hit pause, but continued background activity tells a different story. While deal flow declined, the underlying drivers of M&A activity throughout 2022 (and continuing through today) remain strong.”

Read the full article at genengnews.com.

June 8, 2023 by Duane Morris

Silica Exposure-Related Lawsuits in California Exploding

Silica is an abundant mineral found in materials including sand, stone, and concrete. While serving as a principal component of glass, cement, and ceramics, silica also presents an increasingly pertinent issue for those with interests in toxic torts, as well as businesses involved in the manufacturing or distribution of silica products: occupational exposure to airborne silica, a leading cause of silicosis and lung cancer.

Silicosis is a severe, incurable lung disease that is often fatal. Upon inhalation of fine particles created through workers’ manipulation of the material, small amounts of silica become trapped in the lungs, causing the scarring of lung tissue. Resulting effects are severe, often requiring lifelong care and a possible lung transplant.

Cases commonly appear among those working in construction or mining, and symptoms can present after only a few years of occupational exposure. More often than not, workers use little to no protective equipment, leaving them vulnerable to inhalation of the harmful substance. With the number of silicosis cases on the rise, the issue has been denoted an “emerging epidemic” constituting a “public health problem of great urgency.”

To read the full text of this blog post by Duane Morris partner Robert Kum, please visit the Duane Morris Products Liability Blog.

May 19, 2023 by Duane Morris

Supreme Court Affirms Federal Circuit Ruling Regarding Satisfaction of Enablement Requirement

On May 18, 2023, the Supreme Court of the United States issued its opinion in Amgen, Inc. v. Sanofi, clarifying the standard of satisfying the enablement requirement, in particular, for broad functional genus claims. The Court, in a unanimous decision affirming the Federal Circuit’s holding, focused on whether the specification enabled the full scope of the invention to be practiced.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 6, 2023 by Duane Morris

US FDA Looks to Move Cosmetics Work

Duane Morris attorney Kelly Bonner was quoted in an article in Chemical Watch on March 3.

“The US Food and Drug Administration has started its search for a deputy commissioner for its new human foods programme, and plans to move certain cosmetics functions to another part of the agency to advance oversight of the products. […]

The inclusion of cosmetics in the proposed restructuring is “very significant”, said Kelly Bonner, associate with law firm Duane Morris.

The move will allow the FDA to implement MoCRA more efficiently and effectively, she told Chemical Watch. To this end, the agency “anticipates closer collaboration between cosmetics and other FDA subject matter experts” in the Center for Drug Evaluation and Research and the Office of Women’s Health, she said.”

To read the full text of this article, please visit the Chemical Watch website (subscription required).

February 22, 2023February 23, 2023 by Duane Morris

Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA’s Enactment

On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.

Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products.

To read the full text of this article by Duane Morris attorneys Rick Ball, Alyson Walker Lotman and Kelly Bonner, please visit the Duane Morris website.