Insights on Food, Drug, Medical Device & Cosmetic

Food, Drug, Medical Device & Cosmetic Counsel Abha Kundi will deliver the opening presentation of the Healthcare Distribution Alliance’s (HDA) 2025 Traceability Seminar on August 5, 2025.

On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”

Partner Emily Cowley Leongini was quoted on Sarepta Therapeutics’ decision to pause sales of its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) following a request from the US Food and Drug Administration (FDA).

As artificial intelligence (AI) becomes increasingly embedded in health care, from diagnostics and clinical decision support to administrative automation, health care providers are increasingly reliant on AI vendors to deliver accurate, safe, and compliant solutions, subject to applicable regulatory requirements and standards of care.

Food, Drug, Medical Device & Cosmetic Partner Emily Cowley Leongini will give a presentation titled “Inspections: What to Do if the Government Shows Up at Your Door” at the American Conference Institute’s Food Law and Regulation Boot Camp on July 23.

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”

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.

ArentFox Schiff is pleased to announce that Abha Kundi has joined the firm as Counsel in the Food, Drug, Medical Device & Cosmetic practice in Washington, DC.

The National Environmental Policy Act (NEPA) is a federal statute that outlines how federal agencies must review the environmental impacts of their regulatory actions. The regulated community has often viewed NEPA as an obstacle to a broad range of federal actions in areas ranging from energy permitting to agriculture.

FDA Practice Group Leader Karen Carr was featured on The International Fresh Produce Association’s (IFPA) podcast, Fresh Takes on Tech, in its recent episode “Science and Policy: The Battle Shaping Ag Biotechnology.”

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease.

The Make America Healthy Again (MAHA) Commission, chaired by US Health and Human Services Secretary Robert F. Kennedy Jr., has released its long-anticipated report on childhood chronic disease drivers. Although the document is only an assessment and expressly contains no binding policy recommendations, it signals the contours of a federal strategy that officials will draft within 100 days.

On April 22, at the direction of US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., both the US Food and Drug Administration (FDA) and HHS published identical statements announcing the phase-out of so-called “petroleum-based” synthetic food dyes and their replacement with “natural alternatives.”

There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota.

Join Joy Marie Virga on a panel at the Food Policy Impact 2025 conference.

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

FDA Practice Leader and Agriculture & AgTech Industry Leader Karen Carr will participate in a panel titled “Navigating Regulatory Changes in Seed Treatment” at the 2025 CLA and RISE Regulatory Conference in Arlington, Virginia, on April 24.

Partner Emily Cowley Leongini was quoted on the federal court decision regarding the oversight of laboratory-developed tests by the US Food and Drug Administration.

FDA Practice Leader and Agriculture & AgTech Industry Leader Karen Carr will moderate a fireside chat on agriculture policy at AgBio 2025 in Raleigh, North Carolina, on April 9.

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

As a further update to our alert from March 27, the Trump Administration began mass layoffs at US health agencies on April 1.

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications (NDAs) that relied on bioequivalence studies conducted by Raptim Research Pvt. Ltd, a contract research organization based in Navi Mumbai, India.

Stan Abramson will speak on the Legal Liability Panel at the Biological Products Industry Alliance’s (BPIA) 2025 Annual Meeting in Sacramento, California, on April 2, 2025. His work is focused on chemical, biological, and biotechnology products for agricultural, industrial, and consumer use.

Prop 65 Counsel: What To Know

On March 27, the US Department of Health and Human Services (HHS) announced a significant restructuring initiative in accordance with President Trump’s Executive Order, “Implementing the President’s Department of Government Efficiency Workforce Optimization Initiative.”