I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
1/15/2025
/ Biologics ,
Chevron Deference ,
Chevron v NRDC ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Regulatory Requirements ,
SCOTUS ,
Summary Judgment ,
Supply Shortages
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
11/4/2024
/ Administrative Procedure Act ,
DQSA ,
Drug Compounding ,
Enforcement ,
False Advertising ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Lanham Act ,
Medical Devices ,
Monopolization ,
Patents ,
Popular ,
Proposed Rules ,
Regulatory Agenda ,
Supply Chain ,
Supply Shortages ,
Unfair Competition ,
Weight-Loss Products