Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more
3/27/2025
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Supply Shortages ,
Trademarks ,
Weight-Loss Products
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more
2/17/2025
/ Drug Compounding ,
Final Rules ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
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Regulatory Reform ,
Regulatory Requirements