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 April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase out petroleum-based synthetic dyes from the US food supply by the end of 2026,...more
Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more
Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more
Each year, drug companies recall numerous drugs that they have marketed to patients and healthcare providers in the United States. These recalls come despite drug companies’ obligations to thoroughly test new drugs before...more
On October 30, 2024, the U.S. Food and Drug Administration’s (FDA) newly minted Human Foods Program (HFP) published a list of priority deliverables for Fiscal Year 2025. By way of brief background, FDA designed the HFP to...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
The July 1, 2024 deadline is fast approaching for cosmetic product manufacturers to comply with new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Passage of the...more
“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more
In April, the U.S. Food and Drug Administration (FDA) released the results of its 2023 sampling assignment, testing for asbestos in talc-containing products. The results confirmed the absence of asbestos in all 50 samples...more
Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in a continuing series of posts diving into each...more
On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on new requirements for registration and listing of cosmetic product facilities and products. The draft guidance follows the signing of the...more
While the intention is never to create a product that will be recalled, it is a fairly common occurrence. And while the scope of a recall may vary greatly depending on the product and individual facts at issue, the days...more
While the state of the U.S. Food and Drug Administration’s (FDA’s) regulation of Cannabidiol (CBD) remains gray, the agency now sees a path forward through federal legislation. Here’s what companies in the cannabis industry...more
On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022, as part of the year-end Consolidated Appropriations Act, 2023, added significant new requirements for manufacturers,...more
As 2022 drew to a close, the Wall Street Journal reported that the FDA is finally considering releasing potential guidance regarding cannabidiol (“CBD”) in the coming year. While the exact timeline and scope of the FDA’s...more
With Memorial Day weekend in the rear-view mirror, the nation’s summer vacation season officially has begun. And experts are forecasting that the national pursuits of fun and relaxation in 2022 won’t just be heating up but...more
On May 26, the FDA issued warning letters to four companies alleging that the companies sold unapproved animal drugs containing cannabidiol (CBD). Specifically, these products were intended for use in food-producing...more
On May 13, the FDA issued a public warning regarding reports of accidental ingestion of food products containing tetrahydrocannabinol (THC) by children. The FDA warned that edible products containing THC “can be easily...more
Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing...more
Two prominent vaccine manufacturers submitted requests for authorization of an additional COVID-19 booster dose this week. Meanwhile, as case rates rise in Europe and China, U.S. public health officials take stock of what to...more
This week, early findings of an NIH-backed study were released — showing that a combination of doses from any authorized vaccines is safe and effective. Meanwhile, the Department of Labor shifts focus to a traditional...more
While we enter a new season this week, the same cannot be said for the FDA which, on November 16, reiterated that its approach to regulating the cannabidiol (CBD) industry will be “the same as it ever was”—a regulatory...more
A group of 23 Democratic AGs, led by New York AG Letitia James, petitioned the U.S. Food and Drug Administration (“FDA”) to set limits on the permissible levels of heavy metals in baby food...more