On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel Research, Prime Vitality, Summit...more
12/20/2024
/ Distributors ,
Drug Compounding ,
False Advertising ,
FDA Approval ,
FDA Warning Letters ,
Knockoffs ,
Labeling ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Violations
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 ,
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Regulatory Agenda ,
Supply Chain ,
Supply Shortages ,
Unfair Competition ,
Weight-Loss Products