Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
3/25/2025
/ Deadlines ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Regulatory Requirements ,
Supply Shortages ,
Trademarks
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
1/23/2025
/ Biologics ,
Class Action ,
Daubert Standards ,
Dietary Supplements ,
Expert Witness ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Rules of Civil Procedure ,
Food and Drug Administration (FDA) ,
Injunctive Relief ,
Life Sciences ,
Medical Devices ,
Negligence ,
Over The Counter Drugs (OTC) ,
PFAS ,
Preemption ,
Product Defects ,
Summary Judgment ,
Vaccinations
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
1/19/2024
/ Causation ,
Class Action ,
Cosmetics ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Recalls ,
Liability ,
Life Sciences ,
Medical Devices ,
Multidistrict Litigation ,
New York ,
Over The Counter Drugs (OTC) ,
PFAS ,
Popular ,
Pre-Market Notification ,
Prescription Drugs ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Summary Judgment
For the first time since the passage of the Food, Drug and Cosmetic Act in 1938, the Federal cosmetics law has been substantially updated with the passage of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”)....more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
1/27/2022
/ Breach of Warranty ,
Class Action ,
Consumer Fraud ,
Dietary Supplements ,
Dismissals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
FRCP 12(b)(3) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
New York ,
Pharmaceutical Industry ,
Preemption ,
Premarket Approval Applications ,
Public Health ,
Strict Product Liability ,
World Health Organization
In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...more
The Food and Drug Administration (FDA) has announced that data reviewed on the risks associated with textured breast implants and anaplastic large cell lymphoma (BIA-ALCL) does not require a ban of this medical device under...more