FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...
The FDA has sent its first untitled letter of 2025, hitting Edenbridge Pharmaceuticals with a notice after assessing an exhibit booth panel’s compliance with the rules on promoting prescription ...
According to the FDA, an untitled letter cites violations that do not meet the threshold of regulatory significance for a warning notice. Unlike a warning, an untitled letter does not include a ...
The recent warning and untitled letters have demonstrated that the FDA is reviewing websites and social media to find instances of non-compliant advertisements. Not following FDA regulations can ...
Jim Jones, director of the Food and Drug Administration’s food division, slammed the “indiscriminate firing” of dozens of his employees and recent rhetoric from Health and Human Services Secretary ...