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  2. Food, Drug, Medical Device & Cosmetic

Insights on Food, Drug, Medical Device & Cosmetic

268 total results. Page 4 of 11.

Alerts
FDA Delays Enforcement of Cosmetic Facility Registration and Product Listing Requirements
November 14, 2023
Shoshana Golden, Emily Cowley Leongini

On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing.

Press Release
ArentFox Schiff Earns 62 Top “Best Law Firms” Rankings
November 2, 2023

ArentFox Schiff has been awarded 62 top rankings in the 2024 edition of Best Law Firms® which recognizes firms for professional excellence based on consistently positive ratings from clients and peers.

Alerts
California Bans Several FDA-Authorized Food Additives; New York May Soon Follow
October 25, 2023
Robert G. Edwards, Ph.D.

On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety grounds, the use in food of four additives that are considered safe by the US Food and Drug Administration (FDA). The ban becomes effective January 1, 2027.

Alerts
FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests
October 24, 2023
Jack R. Bierig, Shoshana Golden, Wayne H. Matelski

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs).

Alerts
FDA Announces and Seeks Comments on Cosmetics Direct — Portal for Cosmetic Facility Registration and Product Listing
September 19, 2023
Shoshana Golden, Emily Cowley Leongini

Last Friday, the US Food and Drug Administration (FDA) announced its newly developed draft electronic submission portal — Cosmetics Direct — to facilitate submissions of cosmetic product facility registrations and product listings later this year.

Alerts
FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications
September 11, 2023
Wayne H. Matelski

The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.”

Alerts
FDA Issues New Enforcement Policy for Face Masks and Barrier Face Coverings
September 5, 2023
Wayne H. Matelski

The US Food and Drug Administration (FDA) issued yesterday new guidance on its enforcement policy covering face masks and barrier face coverings.

Press Release
ArentFox Schiff Attorneys Recognized by Best Lawyers, Ones to Watch, and Lawyers of the Year for 2024
August 17, 2023

ArentFox Schiff is pleased to announce that 130 attorneys have been recognized by The Best Lawyers in America 2024, with an additional four attorneys highlighted as “Lawyers of the Year” and 69 attorneys listed as “Ones to Watch.”

Alerts
FDA Draft Guidance Provides Further Details on New Cosmetic Product Facility Registration and Product Listing Requirements
August 9, 2023
Shoshana Golden, Emily Cowley Leongini

Earlier this week, the US Food and Drug Administration (FDA) issued draft Q&A guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products.”

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.

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