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

Insights on Food, Drug, Medical Device & Cosmetic

259 total results. Page 4 of 11.

Consumer Products Watch
FDA Reaffirms It Will Not Prohibit Use of Certain Phthalates as Food-Contact Substances
August 7, 2023
Robert G. Edwards, Ph.D.

On July 21, 2023, the US Food and Drug Administration (FDA) issued a letter denying a request that it reconsider its decision from May 2022 that it would not prohibit the use of eight phthalates as food-contact substances.

Alerts
Lawsuit Forces Early Release of NTP’s Draft Report on Fluoride, and its Potential Association with Neurodevelopment and Cognition
April 4, 2023
Robert G. Edwards, Ph.D.

A lawsuit by anti-fluoridation activists has forced the early release of a long-awaited government report on fluoride and its possible association with neurodevelopment and cognition while the report is still in draft form and prior to completion of its review by independent scientific experts.

Alerts
Modernization of Cosmetics Regulation Act of 2022
February 14, 2023
Brian P. Waldman, Shoshana Golden

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023.

Events
Food Policy Impact 2023
February 7, 2023
Karen Ellis Carr

ArentFox Schiff will host the Food Policy Impact Conference at our Washington, DC, office on February 7-8. AgTech Industry Group Co-Leader Karen Carr is scheduled to present.

Consumer Products Watch
Where In the World Did My Food Come From: FDA’s Food Traceability Rule Takes Effect
January 20, 2023
Karen Ellis Carr, Malerie Ma Roddy

On January 20, 2023, the US Food and Drug Administration’s (FDA) final rule on food traceability will take effect. Regulated entities will have a three-year compliance period, with a current compliance date of January 20, 2026. But what exactly will companies have to do to comply with the new rule?

Alerts
Consolidated Appropriations Act, 2023 Contains Significant Provisions for Cosmetic Products
December 28, 2022
Emily Cowley Leongini, Shoshana Golden

On December 20, 2022, the US Senate unveiled the long-awaited Consolidated Appropriations Act, 2023. The US House of Representatives passed the bill three days later, and it is now awaiting President Biden’s signature.

Press Release
ArentFox Schiff Earns 53 Top-Tier “Best Law Firms” Rankings
November 3, 2022

ArentFox Schiff has been recognized with 53 top rankings in the 2023 edition of US News – Best Lawyers® “Best Law Firms.”

News
Golden and Leongini Quoted on FDA Information Request in Country’s First OTC Daily Oral Contraceptive
November 2, 2022
Emily Cowley Leongini, Shoshana Golden

Partner Emily Leongini and Associate Shoshana Golden were quoted on US Food and Drug Administration’s (FDA) request for additional information from HRA Pharma’s NDA sponsor of a proposal for the country’s first over-the-counter (OTC) daily oral contraceptive.

Events
HDA 2022 Traceability Seminar
October 13, 2022
Brian P. Waldman

Food, Drug, Medical Device & Cosmetic Practice Leader Brian Waldman will present at the Healthcare Distribution Alliance’s (HDA) 2022 Traceability Seminar on October 13.

Alerts
What Is Healthy Food? FDA Proposes To Redefine the Term
October 4, 2022
Robert G. Edwards, Ph.D.

On September 28, 2022, the Food and Drug Association announced a proposed rule to redefine the implied nutrient content claim term “healthy” to more closely reflect current nutrition science and Federal dietary guidelines.

Press Release
ArentFox Schiff Attorneys Recognized by Best Lawyers and Ones to Watch for 2023
August 18, 2022

ArentFox Schiff is pleased to announce that 121 attorneys have been recognized by The Best Lawyers in America 2023, with an additional six attorneys highlighted as “Lawyers of the Year” and 40 attorneys listed as “Ones to Watch.”

News
Steinberg Quoted on Post-Dobbs Creation of AFS Reproductive Health Task Force
July 22, 2022
Jill A. Steinberg

Partner Jill Steinberg spoke with The American Lawyer about ArentFox Schiff’s new Reproductive Health Task Force and the legal challenges that were created when the US Supreme Court overturned Roe v. Wade.

Press Release
ArentFox Schiff Launches Reproductive Health Task Force to Address Legal Issues Following Dobbs Decision
July 12, 2022

ArentFox Schiff LLP announced today the launch of its Reproductive Health Task Force to counsel clients on legal issues stemming from the repeal of Roe v. Wade.

Alerts
Drug Development in the Metaverse
June 17, 2022
Sailesh K. Patel, Matthew T. Wilkerson

“Metaverse” is no longer a mere buzzword. Many industries are discovering and developing applications for the Metaverse, and the pharma and biotech industry is no different.

Alerts
Long COVID – Just the Facts
June 15, 2022
Robert G. Edwards, Ph.D., Wayne H. Matelski, Robert K. Carrol

The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an Alert addressing many of the inquiries we have received.

Press Release
Chambers USA Ranks 66 ArentFox Schiff Attorneys and 25 Practices Among Nation’s Best
June 2, 2022

The 2022 edition of Chambers USA: America’s Leading Lawyers for Business has recognized 66 ArentFox Schiff attorneys as leaders in their field.

Fashion Counsel
From Farm to Runway – The Rise of Regenerative Farming in Fashion
April 1, 2022
Karen Ellis Carr, Katie Heilman, Dan Jasnow

Environmentally responsible fashion has become a key marketing signal for many global brands, with advertising claims such as “sustainable,” “responsibly sourced,” “organic,” and “recycled” cropping up throughout the fashion industry. These claims respond to growing demand from consumers.

Alerts
First Genome-Edited Beef Cattle Cleared for Marketing by FDA
March 14, 2022
Karen Ellis Carr, Rebecca W. Foreman, Mattie Bowden

On March 7, 2022, the US Food and Drug Administration (FDA), operating under its New Animal Drug Authority, took a new, important regulatory step forward in assessing genome editing in animals. Specifically, the Agency announced a “low risk” determination and exercise of enforcement discretion.

Alerts
FCC Announces Working Group Members for Its Precision Agriculture Connectivity Task Force
February 22, 2022
Jeffrey E. Rummel, Karen Ellis Carr

As you know, in our recent Alert, we addressed the announcement of the members of the FCC’s Precision Agriculture Connectivity Task Force (“Task Force). Now, the FCC has announced the new members of the four “Working Groups” that will assist the Task Force in carrying out its work.

Alerts
Is Thanksgiving Over? FDA Serves Fresh Piece of "Real World Data" Pie: Use of Registries
December 2, 2021

This week, FDA published a draft guidance on the use of registries to support regulatory decision-making, titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making or Drug and Biological Products.”

Alerts
New Single-Dose Antibody Injection Effective at Preventing Both Initial COVID-19 Infections and Disease Progression in High-Risk Individuals
December 1, 2021
Robert G. Edwards, Ph.D.

On November 18, 2021, just a few days before the Omicron variant suddenly revealed itself to the world, the preliminary results of two Phase III clinical trials were announced by AstraZeneca, bringing new hope to high-risk populations.

Alerts
Podcast: 10 Minutes for Small Firms and Nonprofits to Better Manage Contracts
November 30, 2021
Brian D. Schneider, Megan Woodward Daily

In this podcast, Brian Schneider and Megan Daily discuss frequently asked questions from small businesses and nonprofits about contract management.

Alerts
New Burdensome FDA Requirements Mandate Reporting Volumes of Almost All Drugs Produced Each Year
November 5, 2021
Shoshana Golden, Wayne H. Matelski

On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a report on the amount of each listed drug produced over the preceding year.

Alerts
All Good Things Must Come to an End: FDA Announces End to Enforcement Discretion for Alcohol-Based Hand Sanitizers
October 15, 2021
Shoshana Golden

As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce alcohol-based hand sanitizers and alcohol for use in such hand sanitizers.

Press Release
Schiff Assists New Owners in Purchase of Oak Park’s Beer Shop
September 30, 2021

In September 2021, Schiff Hardin LLP advised the new owners in the management buyout of the Beer Shop in downtown Oak Park, Ill.

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