Insights on Food, Drug, Medical Device & Cosmetic
268 total results. Page 1 of 11.
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.
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.”
ArentFox Schiff is proud to announce that the firm has been honored by The M&A Advisor, as part of their 19th Annual Turnaround Awards Gala, for “Distressed M&A Deal of the Year ($50MM to $100MM)”, in connection with advising Sutil Group, a leading Chilean agricultural business group, in the acquisition of California-based Sunshine Raisin Corporation.
2025 will be a transformational year for the beverage and food industry, which has already been dramatically impacted by shifting market trends and profound policy changes. Here are the top five topics influencing the strategies and growth plans of beverage and food companies.
On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to “take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe [GRAS] Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.”
Food, Drug, Medical Device & Cosmetic Partner Emily Cowley Leongini will lead a session on dietary supplements during the Food & Drug Law Institute’s (FDLI) virtual Introduction to Food Law and Regulation course on March 11, 2025.
On March 3, the US Department of Health and Human Services (HHS) published a change in policy that could result in fewer opportunities for stakeholders and members of the public to weigh in on HHS regulatory action related to agency management or personnel, public property, loans, grants, benefits, or contracts.
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication.
With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.
In 2025, the retail and fashion industries are bracing for a transformative year, heavily influenced by the policies of the new Trump Administration. These policies promise rapid and significant changes, particularly in areas such as trade, tariffs, and immigration, which will profoundly affect global supply chains and labor dynamics.
On January 13, the chief administrative law judge of the US Drug Enforcement Administration (DEA), John Mulrooney, postponed the highly anticipated hearing on the rescheduling of cannabis under the Controlled Substances Act (CSA), which was set to begin on January 21. The order postpones the rescheduling hearing for at least three months.