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
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
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more
The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more
On January 8, 2025, a bill prohibiting the sale of certain dietary supplements for weight loss and muscle building and other products to minors was formally introduced to the Virginia House of Delegates (House Bill No. 1585...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
ACI and CRN are excited to welcome you back to New York City this Spring for the 11th Legal, Regulatory & Compliance Forum on Dietary Supplements. Since last year, there have been numerous important developments...more
LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...more
In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more
The COVID-19 pandemic spurred record growth in the dietary supplement industry in 2020. With this heightened consumer interest and many new entrants to the market, important questions have emerged about the adequacy of the...more
On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more
Thursday, March 5th, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on FDA action to develop an enforcement discretion policy and evaluate potential regulatory pathways for consumer...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
On Monday, the Food and Drug Administration (FDA) issued its single largest group of enforcement warning letters against 15 companies selling dietary supplements. This represents nearly one-third of the total FDA warning...more
On April 2, 2019, the Federal Food and Drug Administration (FDA) issued a statement and announced a public hearing on consumer products derived from cannabis and its components, including cannabidiol (CBD). ...more
On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Warns About Color Additives, Manufacturing Practices - The U.S. Food and Drug Administration (FDA) has warned three dietary-supplement manufacturers about their marketing and...more
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more
Senate Committee Proposes Cosmetics Regulation Amendment - The Senate Committee on Health has released a discussion draft of a proposed amendment to the Federal Food, Drug and Cosmetic Act (FDCA) that would establish greater...more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more