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Latest From IFM Therapeutics
Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
Webpages misrepresent findings in two clinical studies to overstate efficacy of the Cushing’s syndrome drug and minimize serious risks, Office of Prescription Drug Promotion says. This is second untitled letter issued to Xeris in three years.
In first Rx advertising research project of 2023, FDA will survey consumers on how they interpret quantitative claims in DTC ads. Lilly questions design of another study examining relative importance of product information, citing FDA comments at tanezumab advisory committee.
National Advertising Division refers Gilead’s challenge of ViiV’s advertisements to the FDA and FTC after ViiV declines to participate in its review. Gilead says the ads claim Dovato is superior to its HIV drug Biktarvy, while ViiV suggests a review would amount to second-guessing the FDA.
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