The European Medicines Agency makes its equivalent of FDA manufacturing warning letters public.
Regulators say the company has not received approval for the device's touted functions.
EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
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.
FDA grants Teva three years exclusivity to sell Plan B OTC for all ages; FDA gives Humira a thumbs-down for spondyloarthritis; a UK vaccine committee rejects Novartis' meningitis B shot; and Wockhardt gets a warning letter from FDA for its manufacturing practices at an Indian plant.
PricewaterhouseCoopers says consumers are talking healthcare, but not about the good stuff; Novartis shuffles 120 Texas jobs; 73% of STD app queries came from men last month; FDA is keeping very busy; and OgilvyCommonhealth hires a consumer head
What the agency writes in a recent warning letter to a dietary supplement firm is instructive with regard to "Liking" off-label posts.
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.
The FDA's Office of Prescription Drug Promotion served Sobi and Watson with untitled letters.
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 will study the impact of corrective advertising on consumer misperceptions of drug safety and efficacy.
Pfizer's Lipitor website touted the efficacy of Caduet, Chantix and Norvasc but failed to balance those claims with risk info for the drugs, according to an "untitled letter" from FDA's Division of Drug Marketing, Advertising and Communication (DDMAC).
The FDA's Division of Drug Marketing, Advertising and Communications has written 26% more enforcement letters to drug companies over promotional practices this year than it did in 2009.
Although no product was explicitly mentioned, DDMAC found plenty to dislike about a white paper and other unbranded materials circulated by Tercica, a subsidiary of the Ipsen Group.
New Year's Eve is five months away, but FDA letter-writers have already been prolific in 2010 on themes of risk omission, inflated efficacy claims, and unfair balance presentation as seen in promotional materials targeting physicians and consumers.
The FDA demanded that Jazz Pharmaceuticals halt dissemination of a patient brochure for Luvox CR and run corrective messages to counter inflated benefit claims and omission of risk information.
FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) took Novartis to school over educational websites the agency said went beyond disease awareness, and into brand promotion, according to a Warning Letter dated April 21.
The FDA hit three companies with warning letters for promotional materials on three drugs and requested corrective communications for all three.
Eisai got an FDA untitled letter for two Aricept TV ads that the agency said overstate the efficacy of the drug.
The FDA's Division of Drug Marketing, Advertising and Communications got off to a busy start in January, issuing nine enforcement letters.
The FDA issued an untitled letter upbraiding Lilly for Cymbalta consumer and professional ads.
King's launch of Embeda, a pain drug containing morphine, demonstrates that even supposedly abuse-resistant narcotic products need to take a careful approach in their marketing.
Will the FDA hearings on social media, which kicked off today, result in guidance specific to online media? That's the question on the minds of digital gurus converging on the capitol for two days of presentations on using social media in drug and device marketing.
A promotional card for Sanofi Aventis's Uroxatral omitted indication and risk information, and also used outdated product labeling, according to a DDMAC warning letter.
Video news releases for King's abuse-resistant pain drug Embeda drew a warning letter from FDA's Division of Drug Marketing, Advertising and Communications.
DDMAC issued a warning letter to Allergan that singled out misleading aspects of Latisse's brand.com site.
The FDA issued an untitled letter to J&J for a journal ad for its athlete's foot treatment Ertaczo Cream, saying the ad omits key risk info, broadens the indication and overhypes efficacy.
FDA warned Abbott about a patient testimonial DVD for its HIV drug Kaletra, starring Earvin "Magic" Johnson.