Insights on Food, Drug, Medical Device & Cosmetic

On June 10, the US Food and Drug Administration (FDA) issued a final administrative order adding bemotrizinol to the list of permissible sunscreen active ingredients in the United States – the first new sunscreen active added in 26 years.

On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”

On June 8, the California State Senate adopted Senate Resolution (SR) 104, a measure expressing support for targeting the biological mechanisms of aging as a strategy to prevent and delay chronic disease.

On June 3, the US Food and Drug Administration (FDA) released a revised draft guidance on what drug and device manufacturers can say to health insurers, pharmacy benefit managers (PBMs), formulary committees, and similar organizations about their products.

On June 4, the US Supreme Court issued a unanimous decision authored by Justice Ketanji Brown Jackson in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24–889, delivering a significant win for generic pharmaceutical manufacturers seeking US Food and Drug Administration (FDA) approval for drugs with multiple indications.

Forget science fiction — the race to connect computers directly to the human brain is already underway, and it is accelerating. In recent months, neurotechnology companies have expanded human clinical trials and attracted substantial investment.

ArentFox Schiff’s Gayland Hethcoat on navigating the line between wellness and medical devices in the longevity era.

On April 29, the US Food and Drug Administration (FDA) published a Request for Information (RFI) seeking public comment on a proposed pilot program to test the use of artificial intelligence (AI) in early-stage clinical trials for drugs and biologics. Comments are due June 29.

Until recently, no state or federal law specifically governed ownership or rights in agricultural and livestock data. If ownership allocations were addressed at all, it was by contract.

Food, Drug, Medical Device & Cosmetic Counsel and Longevity & Healthspan Industry Group Co-Leader Abha Kundi will participate in a panel discussion examining the Drug Supply Chain Security Act (DSCSA) on May 21, 2026.

Last year, we reported that Nebraska senators introduced the Agriculture Data Privacy Act (LB525), a first-of-its-kind privacy bill specifically aimed at regulating agricultural-sector data.

Mail and telemedicine access to mifepristone — used together with misoprostol to end an early pregnancy — is in flux following a Fifth Circuit Court of Appeals ruling that restricts mail-order distribution of the medication nationwide, and the US Supreme Court’s subsequent administrative stay restoring the status quo ante on a temporary basis.

On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP-1 receptor agonists by 503B outsourcing facilities.

On April 23, Acting Attorney General Todd Blanche announced a final order reclassifying US Food and Drug Administration (FDA)-approved drug products containing “marijuana” and cannabis products regulated under qualifying state-issued medical marijuana licenses from Schedule I to Schedule III of the Controlled Substances Act (CSA), effective April 28. Critically, adult-use (recreational) cannabis remains in Schedule I.

Everyone is talking about peptides. Your doctor, your trainer, that guy at the dinner party who swears that BPC-157 rebuilt his knee — peptides have officially entered the zeitgeist. But for every breathless testimonial, there is a thicket of regulations that most market participants barely understand.

On April 18, President Trump signed an executive order (EO) directing multiple federal agencies to accelerate research and expand access to psychedelic drugs as potential treatments for serious mental health conditions. The EO represents a notable shift in federal policy toward psychedelic substances and their potential therapeutic use.

The US Food and Drug Administration (FDA) has now escalated its Drug Supply Chain Security Act (DSCSA) findings at Pure Indulgence Aesthetics from a Form FDA 483 (given to the company at the close of a December 2025 inspection) to a formal Warning Letter, issued on April 1.

Forget science fiction — the race to wire computers directly into the human brain is well underway, and it is moving fast.

ArentFox Schiff, in collaboration with Consilio, will host the 2026 Chicago Pharma Forum on May 6, 2026, bringing together pharmaceutical industry leaders and in‑house counsel in the Chicago area for a full day of discussion and networking.

As we continue to move through 2026, the life sciences landscape is shaped by a convergence of regulatory, enforcement, and market access developments that demand heightened attention from industry stakeholders.

The US Food and Drug Administration (FDA) issued a final rule on March 5 that will change National Drug Codes (NDCs) from several different 10‑digit formats to one standard 12‑digit format.

On February 19, the US Food and Drug Administration (FDA) announced a significant shift in its drug approval framework: A single adequate and well-controlled clinical trial, combined with confirmatory evidence, will now serve as the default standard for marketing authorization of new drugs.

As the beverage and food industry enters 2026, companies face a rapidly changing legal environment shaped by an expanding litigation landscape, evolving regulatory frameworks, and renewed transactional activity.

The Centers for Medicare & Medicaid Services (CMS) has released detailed payment amounts, performance targets, and reporting requirements for the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, applicable to care periods beginning July 5 through December 31, 2027.

On February 5, the US Food and Drug Administration (FDA) announced it will now allow food companies to use “no artificial colors” claims when foods do not contain any food, drug, and cosmetic (FD&C)-certified synthetic colors, shifting away from the historical view that such claims were only appropriate where no color was added at all.