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  1. Services
  2. Food, Drug, Medical Device & Cosmetic

Insights on Food, Drug, Medical Device & Cosmetic

268 total results. Page 3 of 11.

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.

Alerts
Top 10 Legal Issues in the Cannabis Industry in 2024
April 17, 2024
Aram Ordubegian, Kirsten A. Hart, Emily Cowley Leongini, Justin A. Goldberg, David P. Grosso, Anthony D. Peluso, Starshine S. Chun*, Tiffany O. Yadegar, Patrick Lai, Robert G. Edwards, Ph.D.

In an industry known for its fast-paced changes, 2024 will be no different for cannabis.

Consumer Products Watch
California Legislature Aims Two More Nails at the PFAS Coffin
April 17, 2024
Robert G. Edwards, Ph.D.

Two bills, quite different in scope but both aiming to further restrict the use or presence of per-and polyfluoroalkyl substances (PFAS) in various products, are currently wending their way through the California legislature.

Events
CLA and RISE Spring Regulatory Conference
April 15, 2024
Karen Ellis Carr

FDA Practice Leader and AgTech Industry Group Co-Leader Karen Carr will speak on a panel on treated seeds at the 2024 CropLife America and RISE Spring Regulatory Conference on April 17, 2024.

Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: April 2024
April 11, 2024
Angela M. Santos, Nancy A. Noonan, Antonio J. Rivera, Leah Scarpelli, James Kim*, Lucas A. Rock, Mario A. Torrico, Kimia Pourshadi, William G. Stroupe II, David Llorente

Welcome to the April 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.

Alerts
California Greatly Expands List of Cosmetics Fragrances Reportable as Allergens
April 9, 2024
Robert G. Edwards, Ph.D.

Since January 1, 2022, California’s Fragrance and Flavor Ingredients Right to Know Act of 2020 has required manufacturers of cosmetic products to disclose the following information to the California Department of Public Health (CDPH):

Fashion Counsel
Cosmetics and “Forever Chemicals”
March 29, 2024
Robert G. Edwards, Ph.D.

PFAS are a large family of synthetic organic chemicals containing carbon chains in which most or all of the hydrogen atoms have been replaced by fluorine.

Alerts
FCC Announces Working Group Members for Its Precision Agriculture Connectivity Task Force
March 28, 2024
Jeffrey E. Rummel, Karen Ellis Carr

The Federal Communications Commission (FCC) has announced the new members of the four “Working Groups” that will continue to assist its Precision Agriculture Connectivity Task Force.

Events
Food Policy Impact 2024
February 27, 2024
Karen Ellis Carr, Rachel A. Remke

ArentFox Schiff will host the Food Policy Impact Summit at our Washington, DC, office on February 27-28, 2024. FDA Practice Leader Karen Carr and Partner Rachel Remke will present on timely developments impacting the food and nutrition regulatory landscape.

Alerts
Beverage & Food Industry in 2024: 10 Hot Topics for Beverage & Food Industry Founders, Investors, and Executives
February 14, 2024
Jay L. Halpern, Amal U. Dave, Emily B. Lewis, Adam Diederich, Daniel J. McQueen, Thorne Maginnis, Nicholas L. Collins, J. Michael Showalter, Dan Jasnow, Linda M. Jackson, Matthew F. Prewitt, Christine R.W. Quigley, D. Reed Freeman Jr.

2023 was a pivotal year for the beverage and food industry globally, creating new categories of winners and losers across the board. With a full year of operations largely relieved of pandemic-era restrictions, restaurant companies that survived the pandemic posted record numbers.

Health Care Counsel Blog
Federal Jury Convicts Six Defendants of Obstructing Access to Reproductive Health Services Facility in Violation of the FACE Act and Other Civil Rights Statutes
February 9, 2024
Jill A. Steinberg, Shoshana Golden

On January 30, a federal jury found six people guilty of federal civil rights offenses arising from their participation in a blockade of a reproductive health care clinic in Mount Juliet, Tennessee.

Events
ACI’s Advanced Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs
January 23, 2024
Shoshana Golden

Food, Drug, Medical Device & Cosmetic Associate Shoshana Golden will give a presentation on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and the intricate regulatory landscape governing cosmetics and over-the-counter (OTC) drugs at the American Conference Institute’s (ACI) Advanced Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs in New York City on January 23-24, 2024.

Press Release
ArentFox Schiff Names Brian Waldman as Firmwide Managing Partner
January 22, 2024

ArentFox Schiff is pleased to announce the selection of Brian P. Waldman as Firmwide Managing Partner, effective January 1, 2024.

Alerts
FDA Announces Availability of Cosmetics Direct Portal and Publication of Final Guidance on Cosmetic Facility Registration and Product Listing
January 4, 2024
Shoshana Golden, Emily Cowley Leongini

On December 18, the US Food and Drug Administration (FDA) announced the availability of the Cosmetics Direct electronic submission portal and publication of final guidance for industry on cosmetic facility registration and cosmetic product listing.

Alerts
FDA Announces Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products
December 21, 2023
Shoshana Golden, Emily Cowley Leongini

On December 14, the US Food and Drug Administration (FDA) issued new instructions for cosmetic companies to use when submitting mandatory serious adverse event reports to the agency.

Consumer Products Watch
Cinnamon and Spice but Not Necessarily Nice
December 18, 2023
Rachel A. Remke

What do eggnog, Christmas pudding, gingerbread cookies, and fruit cake all have in common? Cinnamon. But this year, the spice giving these desserts their holiday cheer could also come with a toxic level of lead.

Alerts
FDA Study Finds Biosimilars Are Interchangeable
December 5, 2023
Wayne H. Matelski

A major new research paper has concluded what many doctors had long believed was true – that patients can be switched between reference (or name brand) biologics and biosimilars with no issues involving the safety profiles or immunogenicity rates of the two drugs.

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