Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
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
On July 15, 2025, Judge Evelyn Padin of the District of New Jersey denied Novartis’s motion for preliminary injunction, which would have blocked MSN Laboratories Pvt. Ltd. from selling a generic version of Novartis’s Entresto...more
Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more
This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are...more
On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more
The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more
A trio of recent cases challenging disparate food and beverage labels offers a few common substantive and procedural lessons for companies. First, the back panels – when considered in light of U.S. Food and Drug...more
Per recent federal employment law guidance, private employers can generally require employees to get vaccinated for COVID-19 as long as they comply with federal employment laws that prohibit discrimination on the basis of...more
2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more
In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...more
A class action lawsuit alleging that Green Roads of Florida LLC misrepresented the amount of CBD contained in various products has been stayed pursuant to the primary jurisdiction doctrine because the plaintiffs’ claims...more
An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019)....more
LEGISLATION, REGULATIONS & STANDARDS - DOJ Announces Guilty Plea in E. Coli Prosecution - The U.S. Department of Justice (DOJ) has announced that Memet Beqiri had pleaded guilty to “a charge related to his meat...more
The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more
Labor and Employment - Jimmy John's Avoids Joint-Employer Finding in Worker Overtime Litigation - In In re: Jimmy John's Overtime Litigation, 2018 WL 3231273 (N.D. Ill. June 14, 2018), a federal district court ruled that...more
The ruling in Lanovaz v. Twinings N. Am., Inc., 2018 U.S. App. LEXIS 15248 (9th Cir. June 6, 2018), settles what was arguably an open issue among district courts within the Ninth Circuit. A plaintiff must have an intent to...more
NOSB Votes to Continue Allowing Hydroponics - The National Organic Standards Board (NOSB) has reportedly voted to continue allowing food grown in water-based nutrient solutions to be labeled “organic,” rejecting a...more
Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more
In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more
Food for Thought is a review of significant court decisions affecting the food, beverage, dietary supplements and personal care products industry. Although many cases in this edition focus on class certification, others...more
Last month we summarized the Second Circuit’s important decision in a dispute between plaintiff-appellee Church & Dwight and its principal competitor, defendant-appellant SPD Swiss Precision Diagnostics, concerning SPD’s...more
In an important recent false advertising decision in a suit brought by home pregnancy test manufacturer Church & Dwight against its principal competitor SPD Swiss Precision Diagnostics, a Second Circuit panel unanimously...more
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more