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
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA rolls out Phase II of long-term sodium reduction plan. FDA has released new,...more
Companies in the food and beverage industry might overlook significant advantages by not patenting their innovations. While there’s a common belief that “recipes” cannot be patented, unique formulations and other aspects of...more
On August 15, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance with new, voluntary sodium reduction targets for foods, with the goal of reducing sodium intake to 2,750 milligrams (mg) per day from the...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Draft Guidance for Sodium Reduction Efforts - The U.S. Food and Drug Administration (FDA) has issued draft guidance that would support reducing the average...more
FDA’s Center for Veterinary Medicine (CVM) recently announced the upcoming expiration of its longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO). This MOU—which has...more
Pivotal food regulatory updates abound in the recently released Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions, announced earlier this month by the White House Office of Management and Budget (OMB). The...more
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
LEGISLATION, REGULATIONS & STANDARDS - FDA Revokes Rule Allowing Brominated Vegetable Oil in Foods - The U.S. Food and Drug Administration (FDA) has revoked its regulation authorizing the use of brominated vegetable...more
We want to inform you of a new law in Maryland, effective January 1, 2025, that mandates baby food manufacturers to test for toxic heavy metals, excluding infant formula. Known as Rudy’s Law, this legislation was inspired by...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
LEGISLATION, REGULATIONS & STANDARDS - UK Labour Party Intends to Ban Energy Drink Sales to Children - The UK Labour Party has signaled that it intends to ban the sale of highly caffeinated energy drinks to those...more
Late last month, San Francisco resident Kirstin Cobbs initiated a class action lawsuit against poppi after purchasing its product, poppi prebiotic soda, believing the product to be “gut healthy.” Poppi sodas are packaged in...more
In the spring edition of the Food & Beverage Digest, our roundup of court cases and litigation trends affecting the food, beverage, agribusiness, and cosmetics industries, we ponder the significance of insignificant, real...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Receives Approval for Reorganization Creating Unified Human Foods Program - The U.S. Food and Drug Administration (FDA) has received approval for a reorganization proposal...more
Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all...more
Our Food & Beverage Team reports good news for the industry: product labels can follow either the Food and Drug Administration’s current version or any new version of a rule defining “healthy.”...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
LEGISLATION, REGULATIONS & STANDARDS - FDA Approves Qualified Health Claims for Yogurt - The U.S. Food and Drug Administration (FDA) will allow qualified health claims asserting the consumption of yogurt is associated...more
The U.S. Food and Drug Administration (FDA) announced certain food-packaging materials containing per- and polyfluoroalkyl substances (PFAS) will no longer be sold in the U.S. PFAS are a large, diverse, and complex family of...more
LEGISLATION, REGULATIONS & STANDARDS - 20 State AGs Ask FDA to Act on Lead, Metals in Baby Food - Citing a wave of childhood lead poisoning connected to recalled applesauce pouches, a group of 20 state attorneys...more
Attend ACI’s 8th Advanced Summit on Food Law – Regulation, Compliance and Litigation and obtain the tools and techniques you need to meet the legal and regulatory challenges which the food industry is now facing as well as...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