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 Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd., the Court of Appeals for the Federal Circuit (CAFC) held that the optional product storage temperatures stated in Rubicon’s proposed generic product label did...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more
On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous guidance document dated...more
With the dissolution of the U.S. Department of Justice’s Consumer Protection Branch set to occur by Sept. 30, a vital question that remains to be fully answered is who will be responsible for litigation matters typically...more
A court-approved agreement brings welcome certainty for retailers selling vapor and nicotine-pouch products in Alabama—confirming that companies with a standard tobacco license may continue selling FDA-authorized products,...more
On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more
Today's marketplace is a crowded space, with products and services facing intense competition for customer attention and spending. Shelves are filled with new and improved products, consumer attention is fragmented across...more
ACI’s 3rd Annual West Coast Legal, Regulatory and Compliance Forum on Cosmetics & Personal Care Product is the must-attend event for cosmetics and personal care professionals looking to navigate the toughest legal,...more
President Trump has indicated he may ease federal restrictions on marijuana, specifically by rescheduling cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). This would be the first move his...more
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
Life sciences companies racing to harness artificial intelligence often stumble into preventable traps that can derail innovation and create lasting legal exposure. ...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025...more
FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more
On July 30, the US Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT), a new science-based tool designed to screen and evaluate the safety or toxicity of chemicals in food....more
A concept once confined to speculative and science fiction, artificial intelligence (AI) therapists – in the form of online chatbots – now exist and are available for use in the present day. Some of them have been developed...more
The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and...more
On July 29, 2025, during a joint press conference, the U.S. Food and Drug Administration (FDA or the Agency) recommended to the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH) as a Schedule I...more
The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more
The medications we take are supposed to protect our health and help us recover from serious illnesses and injuries. Unfortunately, this doesn’t always happen. Some medications cause more harm than good. Dangerous and...more
Last week, former Food and Drug Administration (FDA) Commissioner David Kessler submitted a citizen petition urging FDA to revoke the generally recognized as safe (GRAS) status of refined carbohydrates used in industrial food...more
The United States Food and Drug Administration (“FDA”) recently issued a proposed rule to extend the compliance date for the final rule “Requirements for Additional Traceability Records for Certain Foods” (the “Traceability...more
The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
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