Perspectives on Food, Drug, Medical Device & Cosmetic
244 total results. Page 1 of 10.
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Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical needs for serious or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.
Prop 65 Counsel: What To Know
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.
Welcome to the November 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
AgTech Associate Rebecca Foreman will present at the American Agricultural Law Association’s (AALA) 2024 Annual Educational Symposium in Memphis, Tennessee, on November 9, 2024.
ArentFox Schiff has been nationally recognized with 35 top rankings in the 2025 edition of Best Law Firms®, which honors firms for professional excellence based on consistently positive ratings from clients and peers.
This past August, the US Drug Enforcement Administration (DEA) announced plans to hold an administrative hearing on its proposal to move “marijuana” from Schedule I of the Controlled Substances Act — the most restrictive category — to Schedule III.
AFS successfully represented Sutil Group, a leading Chilean agricultural business group, in the acquisition of California-based Sunshine Raisin Corporation, one of the top processors of premium-quality dried fruits in the United States.
Prop 65 Counsel: What To Know
Food, Drug, Medical Device & Cosmetic Partner Emily Cowley Leongini will lead a session on dietary supplements in the Food & Drug Law Institute’s (FDLI) virtual Introduction to Food Law and Regulation course on September 18, 2024.
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing Program, particularly with respect to contract pharmacies.
ArentFox Schiff is pleased to announce that 135 attorneys have been recognized by The Best Lawyers in America 2025, with two attorneys highlighted as “Lawyers of the Year” and 70 attorneys listed as “Ones to Watch.”
On July 16 the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) jointly issued warning letters to five companies for illegally selling “copycat” food products containing delta-8 tetrahydrocannabinol (THC).
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules.
On July 2, the US Department of Agriculture (USDA) Animal and Health Inspection Service (APHIS) published a Request for Information (RFI) seeking public comment on the improvement of regulatory processes governing genetically engineered microorganisms — referred to as ‘modified microbes.’
On the final day of its term, the US Supreme Court rejected the principle of “administrative finality,” an additional blow to federal agencies after the Court rejected “Chevron deference” the previous day.