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
In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute. Biogen Int'l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. 2020). Section 156 of...more
The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more
4/16/2019
/ Administrative Proceedings ,
Causation ,
Civil Conspiracy ,
Compensatory Damages ,
Court of Federal Claims ,
Declaratory Rulings ,
Department of Health and Human Services (HHS) ,
Design Defects ,
Dismissals ,
Exhaustion Doctrine ,
Food and Drug Administration (FDA) ,
Fraud ,
Injunctive Relief ,
Lack of Jurisdiction ,
Manufacturer Liability ,
National Childhood Vaccine Act of 1986 ,
Preemption ,
Res Judicata ,
Vaccinations