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
Call to Action. In a letter dated July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a clear call to action for manufacturers, distributors, and retailers of infant formula, baby food, and children’s food...more
With food policy remaining a top priority for the Trump Administration, the U.S. Food and Drug Administration (FDA), acting under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has swiftly advanced a number...more
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more
Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more
Louisiana's Senate Bill 14 introduces a first-of-its-kind QR code labeling mandate for food products containing any of 44 specified ingredients, effective Jan. 1, 2028. The legislation follows Texas Senate Bill 25, which...more
Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more
Defective medical devices can present serious—and even life-threatening—risks for patients. Yet, sadly, many patients don’t realize that their medical devices are defective until it is too late. Sometimes, manufacturers and...more
The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking chemicals in the food supply. According to the document, the systematic post-market assessment of food...more
The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more
The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more
On June 18, the US Food and Drug Administration (FDA) released for public comment a proposed method for ranking chemicals present in the food supply to determine which should be prioritized for post-market safety assessments....more
On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) announced plans to update its food safety post-market chemical review program over the next few months to increase transparency and accelerate its...more
On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more
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
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more
To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more
What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more