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Cosmetics Medical Devices

ArentFox Schiff

MoCRA Compliance: Key Legal Issues for Fashion Houses with Cosmetics

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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. As compliance deadlines for these new...more

Gardner Law

FDA Issues Numerous Warning Letters

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The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Venable LLP

Marketing FDA-Regulated Products: An Excerpt from the Advertising Law Tool Kit

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The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

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From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

American Conference Institute (ACI)

[Event] 10th Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products - March 28th - 29th, New York, NY

The cosmetics industry is undergoing massive change, with the newly passed “Modernization of Cosmetics Regulation Act 2022”. At American Conference Institute’s 10th Annual Forum on Cosmetics & Personal Care Products join our...more

Jones Day

Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

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In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more

Akin Gump Strauss Hauer & Feld LLP

Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues

In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more

Mintz - Health Care Viewpoints

FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic...

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation...more

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

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The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

McDermott Will & Emery

Intellectual Property & Health | News To Know – June 2022

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RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

Faegre Drinker Biddle & Reath LLP

New Phthalates Study Garnering Media Attention Purports to Show Only an Association – Not Causation – with Certain Mortalities

A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations.  Some media coverage of this study blurs the important distinction between “association” and...more

Akerman LLP - Health Law Rx

Updated for Expanded DDC Interpretation: New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and...

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come.  When an applicant files for a change of ownership (“CHOW”) or change of location for one...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #4

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Food/Dietary Supplements - FDA Provides Update on Frozen Berry Sampling – The FDA stated, “As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #2

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Food/Dietary Supplements - Court Enters Consent Decree Against Food Facility – A Michigan-based food manufacturer will “discontinue selling food products until the company complies with federal regulations and other...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 1

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Welcome to 2019! We hope that your New Year’s resolutions included time to sit down and enjoy our latest edition of Pro Te: Solutio. We have three intriguing articles in this edition, which are sure to provide useful...more

BakerHostetler

FDA and Pharmacy Weekly Digest - March 2019 #2

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FDA Commissioner Announces Resignation – Food and Drug Administration Commissioner Scott Gottlieb announced his resignation, citing personal reasons. ...more

Farrell Fritz, P.C.

Legislation Affecting the Pharmaceutical Industry

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During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills,...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Mintz - Consumer Product Safety Viewpoints

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

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Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

K&L Gates LLP

Global Food, Drug and Medical Device Newsletter

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In this issue: Legislative Updates: - (i) USA - (ii) EU - (iii) China - (iv) Australia - (v) Japan. - Featured Articles: - (i) Caffeinated Energy Drinks - a Global Perspective - (ii)...more

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