The U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently posted a warning letter (the “Letter”, issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO,...more
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
9/18/2024
/ Advertising ,
Direct to Consumer Sales ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Labeling ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Television Commercials
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more
On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Exeltis USA Inc. (Exeltis) regarding a promotional social media sponsored post...more
As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27...more
On June 2, 2022, the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Althera Pharmaceuticals, LLC (Althera) relating to promotional communication for ROSZET®...more