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Insights on Food, Drug, Medical Device & Cosmetic

259 total results. Page 2 of 11.

Alerts
Prop 65 Roundup - November 2024
November 22, 2024
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D., Shayshari Potter

Prop 65 Counsel: What To Know

Health Care Counsel Blog
The 2025 Final Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need to Know
November 21, 2024
Stephanie Trunk, Shoshana Golden

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 CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.

Customs Newsletter Featured Web Banner
Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: November 2024
November 18, 2024
Angela M. Santos, David R. Hamill, Antonio J. Rivera, Nancy A. Noonan, Lucas A. Rock, Mario A. Torrico, James Kim*, Maya S. Cohen, Derek Ha, William G. Stroupe II, Jodi Tai, Birgit Matthiesen, Kelsey Griswold-Berger*

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.

Events
AALA 2024 Annual Educational Symposium
November 9, 2024
Rebecca W. Foreman

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.

Press Release
US News and Best Lawyers Rates 35 ArentFox Schiff Practices Among Best in the Country
November 7, 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.

Alerts
DEA Hearing on Proposal to Reschedule Marijuana Pushed to 2025
November 6, 2024
Emily Cowley Leongini, Kirsten A. Hart, Justin A. Goldberg, David P. Grosso, Aram Ordubegian

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.

Press Release
ArentFox Schiff Advises Sutil Group in Sunshine Raisin Acquisition
November 6, 2024

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.

Alerts
Prop 65 Roundup - October 2024
October 25, 2024
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D., Shayshari Potter

Prop 65 Counsel: What To Know

Events
FDLI Introduction to Food Law and Regulation 2024
September 18, 2024
Emily Cowley Leongini

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.

Health Care Counsel Blog
The 340B ‘Saga’ Continues: As More States Pass 340B Contract Pharmacy Laws, More Lawsuits Follow
September 3, 2024
Douglas A. Grimm, Stephanie Trunk, Gayland O. Hethcoat II, Shoshana Golden

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.

Press Release
More Than 130 ArentFox Schiff Attorneys Recognized by Best Lawyers in 2025
August 16, 2024

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.”

Alerts
More Delta-8 THC Foods Target of FDA and FTC Enforcement
July 24, 2024
Shannon Rieger, Emily Cowley Leongini

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).

Health Care Counsel Blog
The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need to Know
July 17, 2024
Stephanie Trunk, Shoshana Golden

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.

Alerts
USDA’s Biotechnology Regulator Issues Much-Anticipated RFI on Regulation of Modified Microbes
July 15, 2024
Karen Ellis Carr, Rebecca W. Foreman

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.’

Environmental Law Advisor
SCOTUS Update: Corner Post Decision Upends Concept of Administrative Finality and Expands Timeframe for Administrative Challenges
July 3, 2024
Michael K. Molzberger, J. Michael Showalter

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.

News
Leongini Quoted on the Future of Cosmetics Regulation Under MoCRA
July 1, 2024
Emily Cowley Leongini

Partner Emily Cowley Leongini was quoted in a recent Axios article on the Food and Drug Administration’s implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which established a July 1 deadline for companies to register their products and facilities with FDA.

Environmental Law Advisor
Nine Questions, Nine Answers: The Supreme Court’s Decision Overruling ‘Chevron Deference’
July 1, 2024
J. Michael Showalter, Michael K. Molzberger, Samuel A. Rasche

On the second-to-last day of its term, the US Supreme Court issued its decisions in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Dep’t of Commerce.

Events
DEA Rescheduling: Navigating the Regulatory and Financial Changes for Cannabis Companies
June 28, 2024
Emily Cowley Leongini, Justin A. Goldberg, David P. Grosso

ArentFox Schiff Partners Emily Leongini, Justin Goldberg, and moderator David Grosso discuss the potential implications of the DEA’s rescheduling proposal on cannabis companies around the country.

Environmental Law Advisor
SCOTUS Update: Supreme Court Clarifies Organizational Standing in FDA-Related Ruling
June 28, 2024
J. Michael Showalter, Jill A. Steinberg, Stephen Blake, Shoshana Golden, Sarah L. Lode

A recent US Supreme Court decision, which grabbed headlines because it involved an abortion-related drug, with potential repercussions in litigation far-removed from health care due to the decision hinging on “standing,” i.e., when parties have been injured in a manner permitting them to sue.

Alerts
MoCRA Compliance: Key Legal Issues for Fashion Houses with Cosmetics
June 21, 2024
Anthony V. Lupo, Emily Cowley Leongini, Shoshana Golden

As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States.

Press Release
Two Attorneys Named 2024 Client Service All-Stars by BTI Consulting
June 17, 2024

ArentFox Schiff is pleased to announce that Firmwide Managing Partner Brian Waldman and Partner Caroline Turner English have been named to the BTI Client Service All-Stars 2024, independently researched, client-driven ranking of attorney client service.

Alerts
Deadline to Register Cosmetic Facilities and List Cosmetic Products Fast Approaches
June 14, 2024
Shoshana Golden, Emily Cowley Leongini

Companies subject to the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) should take note that the deadline to register cosmetic facilities and list cosmetic products is fast approaching on July 1, 2024.

Events
Webinar: Due Diligence for Life Science Companies
June 12, 2024
Stephanie Trunk, D. Jacques Smith

Join ArentFox Schiff Partners Stephanie Trunk, a recognized authority in government pricing and compliance, and Jacques Smith, a leading health care litigator with extensive experience guiding life science companies through government inquiries, as they share key insights and aim to equip participants with the knowledge to effectively manage due diligence in life science mergers and acquisitions.

Alerts
Da Brat and The Latest (Rap) Battle: FDA Expected to Drop Sperm Donation Ban for Gay Men
June 11, 2024

Under current US Food and Drug Administration (FDA) guidance, sexually active gay and bisexual men are prohibited from anonymously donating sperm.

Alerts
BIS Authorizes Medical Device Exports to Russia, Belarus, and Occupied Ukraine (With Strings Attached)
April 30, 2024
Derek Ha, Kay C. Georgi

License Exception MED, published by the US Department of Commerce’s Bureau of Industry and Security (BIS) on April 25, authorizes the export, reexport, or in-country transfer of EAR99 “medical devices” to non-military hospitals but comes with new restrictions and due diligence requirements.

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