When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
3/26/2025
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Draft Guidance ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Public Health ,
Regulatory Requirements ,
Risk Management ,
Warning Letters