Insights on Food, Drug, Medical Device & Cosmetic
259 total results. Page 1 of 11.
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.
Prop 65 Counsel: What To Know
The United States has prevailed in a dispute against Mexico under the United States-Mexico-Canada Agreement (USMCA) concerning genetically modified (GM) corn.
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.
On January 6, the US Food and Drug Administration (FDA) published in the Federal Register a notice announcing its determination that 35 previously authorized Food Contact Notifications (FCNs) for food contact substances containing per- or polyfluoroalkyl substances (PFAS) are no longer effective.
Happy New Year and welcome to US cosmetics regulation in 2025! With many provisions of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) already in effect and others still waiting in the wings, let’s discuss where the US Food and Drug Administration’s (FDA) regulation of cosmetics stands as of January 1, 2025.
Two years after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) has published the long-awaited proposed rule on talc-containing cosmetics.
Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical needs for serious or life-threatening conditions. As usual, the FDA is soliciting comments to the new guidance, due by February 4, 2025.
On December 12, the US Food and Drug Administration (FDA) announced the availability of updated final guidance on cosmetic facility registration and cosmetic product listing. If you are experiencing déjà vu, you are not alone — the FDA announced the issuance of the same final guidance almost exactly one year ago, on December 18, 2023.
There is significant potential that the Congressional Review Act (CRA) will play a prominent role in the early weeks of the Trump Administration. Below, we will break down what the CRA is, when it applies, and how it may be deployed by the incoming US Congress to further Trump Administration regulatory priorities.