The marketing watchdog's untitled letter says a direct mailer failed to disclose "material facts" from the warnings and precautions section of the PI.
Regulators say the company has not received approval for the device's touted functions.
The agency's bad-ad warning letter calls the new violations "particularly troubling."
The FDA's Bad Ad group says the drugmaker misbranded its cholesterol drug during interviews on CNBC.
The agency made good on a pledge to expand Bad Ad with a web-based CME course and case studies representing common problems.
FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.
GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.
The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.
The duo whose nonprofit served as neutral ground for getting FDA and industry talking about digital marketing is starting a for-profit research and advisory firm.
The Wizards of White Oak are spending $10 million on DTC ad research. Is this a wise use of sparse agency resources?
The bad-ad group has hit the drug maker with an untitled letter, saying the print piece's type treatment and other elements mislead patients.
Aveo CRL says company's kidney drug information is uninterpretable; Dynavax has to find more hepatitis B clinical trial patients; Gilead's hep C drug gets priority status; OPDP slaps Janssen and Sigma Tau with untitled letters.
Plan B age limits retained and rejected, Celgene drugs gets expanded indication, Komen cuts back on walks, Apple is policing medical apps, OPDP director's Q&A
The FDA wants to know how physician attitudes towards direct-to-consumer advertising have evolved since the agency last asked them, in 2002. If a snap poll by CMI/Compas is any indication, drug companies probably won't like the answers.
FDA's Office of Prescription Drug Promotion is taking an integrated approach to reviewing promotional materials and shedding its consumer- and professional-directed silos.
What the agency writes in a recent warning letter to a dietary supplement firm is instructive with regard to "Liking" off-label posts.
With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss.
PhRMA issued a terse response to a study claiming that ED drug advertisers more or less ignored the trade group's Guiding Principles for Direct to Consumer ads, a self-policing regime implemented in 2005 to fend off talk of a ban on drug ads.
A Merck study bolsters FDA's case for requiring that TV ads for prescription drugs present risks in text as well as the voiceover.
AstraZeneca's 7,300 layoffs were not the last word for 2012, Alcon gets hit with an untitled letter from OPDP, and Novo creates an all-diabetic sports team
The FDA has issued a rare untitled letter concerning a pitch letter - a reminder that the agency does not consider press materials to be exempted from its oversight.
FDA's objections include overstated efficacy and misleading art.
The drug industry may be settling in for a hot, lazy summer, but FDA's Office of Prescription Drug Promotion has been keeping busy, issuing untitled letters to Pfizer, Valeant and Acorda Therapeutics over allegedly violative promotions in recent weeks.
The FDA's Office of Prescription Drug Promotion served Sobi and Watson with untitled letters.
The FDA plans to study whether consumers can distinguish between product claims and disease information in print ads for prescription drugs.
FDA's Office of Prescription Drug Promotion issued a warning letter to Mylan and Pfizer for an EpiPen TV ad that the agency said hyped the effectiveness of the drug.
The FDA's draft guidance on a planned move to mandate pre-review of TV ads for most prescription drugs and biologics would be unduly burdensome, say manufacturers, and maybe unconstitutional, says PhRMA.
TV ads for most prescription drugs must be submitted to FDA for pre-clearance 45 days before the manufacturer intends to air them, according to an FDA draft guidance in tomorrow's Federal Register.
The FDA will study the impact of corrective advertising on consumer misperceptions of drug safety and efficacy.
An FDA study looking at the power of background visuals to distract viewers from the often-ominous risk info read in the "major statement" section of TV drug ads found no evidence that consumer understanding of risk info is affected by the "emotional (affective) tone of images.