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
Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...more
With six more decisions, the U.S. Supreme Court decided no fewer than 11 cases in two business days last week, following 12 others over the previous two weeks. In other words, summer vacation is upon us, as the Court’s...more
The United States District Court for the Southern District of New York (the “District Court”) recently issued a decision that rejected a common industry practice for trustees to be removed, appointed or to take actions based...more
A recent US Supreme Court decision, which grabbed headlines because it involved an abortion-related drug, with potential repercussions in litigation far-removed from health care due to the decision hinging on “standing,”...more
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more
The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more
On Thursday, June 13, the Supreme Court of the United States issued three decisions: FDA v. Alliance for Hippocratic Medicine, No. 23-235: This case involves an attempt to rescind the Food and Drug Administration’s...more
On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with misoprostol, was used in nearly two-thirds of all U.S. abortion and miscarriage treatments...more
On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more
On June 13, 2024, the U.S. Supreme Court decided Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 23-235, together with Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, No. 23-236,...more
The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact....more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...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
Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more
On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more
Insurers have prevailed in several lawsuits filed by restaurants in connection with losses related to COVID-19. For example, in Emerald Coast Restaurants, Inc. v. Aspen Specialty Ins. Co., No. 3:20cv5898-TKW-HTC, 2020 WL...more
Judge Robert Scola refused to apply the primary jurisdiction doctrine to stay a class action based on the alleged misrepresentation of the amount of CBD in products sold by Diamond CBD, diverging from Judge Ursula Ungaro’s...more
When America’s war on heart disease was kicked into gear by President Eisenhower’s heart attack in 1955, dietary fat was deemed the culprit. In an effort to improve health, people sought low-fat alternatives to their favorite...more
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more
Welcome to our first Product Lines issue of 2020. Product Lines is our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely...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
A recent Eleventh Circuit decision took a broad view of what type of economic injury is sufficient to confer Article III standing, concluding that two dietary supplement companies’ alleged violations of a federal statute...more
LEGISLATION, REGULATIONS & STANDARDS - Senate Confirms FDA Commissioner - The U.S. Senate has voted to confirm Stephen Hahn as the commissioner of the U.S. Food and Drug Administration (FDA). Hahn, an expert in...more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more