The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released its third untitled letter of 2019 because of a direct-to-consumer video on Aclaris ...
The authors felt that FDA must be singing (in the hallways) Queen’s 1979 hit “Don’t Stop Me Now” as it continues its strong enforcement push. As pharmaceutical companies prepare promotional strategies ...
The Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) recently issued a Notice of Violation (“NOV”) to a drug company regarding a television advertisement the agency ...
Bayer received an FDA Untitled Letter this week for its prostate cancer drug Nubeqa, shortly after it launched a lawsuit ...
In the most recent Untitled Letter, regulators said language around “fast and lasting responses,” organ-level benefits and ...
Company initiated a comprehensive review of promotional materials and is implementing enhanced advertising compliance measures, including expanded promotional review protocols, executive training, and ...
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