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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA),...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more
This article follows our introduction to the alternative protein industry and the legal considerations for companies and investors operating within it. The focus of this article is on the regulation of insects as food and...more
This article discusses the global developments for the registration of cannabis and cannabis-related trademarks in the United States, Canada, Mexico, and the European Union....more
LEGISLATION, REGULATIONS & STANDARDS - ASA Upholds Complaints Against Ads Targeting Children - The U.K. Advertising Standards Authority (ASA) has upheld the Obesity Health Alliance’s complaints against advertisements...more
LEGISLATION, REGULATIONS & STANDARDS - Hawaii Bans Two Sunscreen Ingredients - The Hawaii legislature has passed a law that will prohibit the sale or distribution of sunscreen containing oxybenzone and octinoxate after...more
Senate Committee Proposes Cosmetics Regulation Amendment - The Senate Committee on Health has released a discussion draft of a proposed amendment to the Federal Food, Drug and Cosmetic Act (FDCA) that would establish greater...more
Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more
Chicago Repeals SSB Tax After Two Months of Enforcement - Chicago officials have voted to repeal a sugar-sweetened beverage (SSB) tax approved in November 2016 by the Cook County Board of Commissioners but delayed by a...more
Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more
Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more
King & Spalding is pleased to provide this first edition of the International Food Law Gazette, a publication of our Food & Beverage Group. For decades, King & Spalding has closely advised leading food, beverage and dietary...more
Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more
Over the last few weeks, two big stories have made headlines in the food industry. Beginning in early February, news media across Europe began reporting that food products tested in several European countries contained...more