Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
In recent years, plaintiffs have increasingly set their sights on kratom, a controversial botanical supplement, as a target for litigation. With at least 15 putative class-action cases filed in the past year alone, this...more
Clean Beauty Legal Risks Clean beauty claims have become the current "flavor of the month" for consumer class action lawsuits, particularly in California, New York, Florida, and Texas, where plaintiff's bar activity is...more
Microplastics are small plastic particles released from plastic products as they break down over time, and they are present everywhere in the environment . Although there is not yet conclusive scientific evidence...more
In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...more
Attend ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to stay ahead of the latest environmental and sustainability developments impacting cosmetics and personal care products...more
On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more
This year, a laboratory issued a report wherein it claims to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In...more
Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more
Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more
Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more
MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more
MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more
American Conference Institute in collaboration with the Council for Responsible Nutrition (CRN) are excited to welcome you back to New York for the “return to live” reunion that the dietary supplements industry has been...more
In August 2018, the Province of British Columbia (Province) commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholesalers, and...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
Heavy metals, such as arsenic, lead, cadmium, and mercury, are present in baby foods produced by U.S. baby food manufacturers according to a report released in February by the U.S. House of Representatives Subcommittee on...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...more
A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more
CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more
Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more
Prepare to meet the challenges of the rapidly evolving legal and regulatory landscape of the cosmetics and personal care products industry. A new paradigm is emerging in 2019. Ensure you are prepared to meet the global...more
The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more
Shook Partners Lindsey Heinz and Katie Gates Calderon, with Associate Hillary Nicholas, have authored an article for Law360 discussing regulations related to the use of photography during a U.S. Food and Drug Administration...more