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 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 FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more
In response to increased concerns regarding insufficient personal protective equipment (“PPE”), the FDA recently issued an Emergency Use Authorization (“EUA”) applicable to face masks for use by both the general public and...more
4/28/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Distributors ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Healthcare Workers ,
Immunity ,
Manufacturers ,
Masks ,
Personal Protective Equipment ,
Public Readiness and Emergency Preparedness Act (PREP Act)
The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more