In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more
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
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more
On December 29, 2022, President Biden signed into law H.R. 2617, the Consolidated Appropriations Act of 2023 (CAA23). Buried in this massive piece of legislation is Section 3621, Regulation of Certain Products as Drugs, which...more
By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more
Mid-year update: Health products approved in 2021 – In October 2021, Health Canada published a “Mid-year update: Health products approved in 2021”, which provides an update on the drugs, medical devices, over-the-counter...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more