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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
While it rarely rules on questions of preemption, the Ninth Circuit took an even rarer step on July 1, 2024 when it took up the question of whether private parties can seek to enforce the provisions of California’s Sherman...more
In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more
Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs,...more
MASSACHUSETTS - First Circuit Holds Putative Class Action Claims Alleging Deceptive Practices In Labeling of Lactase Product As Dietary Supplement Instead Of Drug When Product Claimed To Treat Lactose Intolerance...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
PERKINS COIE IS PLEASED TO PUBLISH ITS Q4 FOOD AND CPG LEGAL TRENDS REPORT. This report is a bite-sized version of our annual year in review, providing timely insights on trends so far this year. In Q4 2023, the Consumer...more
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more
On August 14, 2023, a panel of judges for the United State Court of Appeals for the Ninth Circuit issued a published opinion affirming dismissal of two complaints alleging that food product labels advertising the amount of...more
A new year has arrived, and with it come new FDA requirements governing the labeling and safe handling of sesame and sesame-containing food products. The seed, a popular ingredient in foods across the world, has joined the...more
On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more
Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein...more
Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary...more
While the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) only makes a minor change to add sesame as a major food allergen, it signals the government’s intent to closely examine food allergen...more
US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal Food ...more
On 14 April 2021, the U.S. Congress passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 (S. 578), which now heads to the White House for signature. ...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
On December 7, 2020, the Seventh Circuit joined three other circuits—the First, Second, and Ninth—in holding that an accurate fine-print list of ingredients does not foreclose, as a matter of law, a claim that an ambiguous...more
AquaBounty Technologies’ path to the U.S. market for its genetically engineered (GE) salmon has been a long one. In 2015, the FDA approved AquaBounty’s application to create and farm its GE salmon (trade name, AquAdvantage)...more
On 10 November 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance recommending that companies voluntarily declare sesame in the ingredient list when it is used as a “flavor” or...more
Federal food-labeling laws preempt state laws that impose requirements different from or in addition to those established by federal law. In some cases, the FDA has spoken directly to a labeling issue by regulation, and if...more
The Food, Drug, and Cosmetic Act (FDCA) promotes nationwide uniformity in food labeling by establishing a comprehensive federal labeling scheme and preempting state law that imposes different requirements. 21 U.S.C. §...more
On April 1, 2020, FDA issued a guidance document instructing companies on how to notify the agency of a permanent discontinuance or interruption of manufacturing of certain products pursuant to Section 506C of the FDCA (21...more
April 8, 2020 Publications The federal Food and Drug Administration (“FDA”) released two guidance documents to provide restaurants and food manufacturers with additional flexibility in distributing food during the COVID-19...more
On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the...more