Warning Letter

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

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The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

EMA publishes noncompliance letters

The European Medicines Agency makes its equivalent of FDA manufacturing warning letters public.

FDA slams 23andMe over genetic testing device

FDA slams 23andMe over genetic testing device

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Regulators say the company has not received approval for the device's touted functions.

Researcher finds black-box drugs have high Warning Letter risk

EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.

Merz web-copy shortcuts don't sit well with OPDP

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FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.

Business briefs: GlaxoSmithKline and Spectrum

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.

OPDP sends Warning Letter to Acorda

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The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.

Business briefs: Teva, AbbVie, Novartis, Wockhardt

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.

Business briefs: PwC, Novartis, iDoc24, FDA

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

AMARC Angst: Has FDA put pharma Facebook "Likes" in the crosshairs?

AMARC Angst: Has FDA put pharma Facebook "Likes" in the crosshairs?

What the agency writes in a recent warning letter to a dietary supplement firm is instructive with regard to "Liking" off-label posts.

With untitled letter, FDA signals press materials aren't exempt

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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.

Sobi, Watson get OPDP untitled letters

Sobi, Watson get OPDP untitled letters

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The FDA's Office of Prescription Drug Promotion served Sobi and Watson with untitled letters.

OPDP wants corrective ads for violative EpiPen TV spot

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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.

FDA to study "corrective" ads

FDA to study "corrective" ads

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The FDA will study the impact of corrective advertising on consumer misperceptions of drug safety and efficacy.

Lipitor.com gets Bad Ad slap for cross-promotion sans risk info

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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).

DDMAC enforcement letters up 26% in 2010

DDMAC enforcement letters up 26% in 2010

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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.

DDMAC calls Ipsen white paper misleading, serves warning letter

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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.

DDMAC regulatory letters could double in 2010

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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.

Luvox CR patient brochure gets warning for missing risk info

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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.

DDMAC warns Novartis on educational websites

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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.

DDMAC demands corrective messaging from three companies

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The FDA hit three companies with warning letters for promotional materials on three drugs and requested corrective communications for all three.

Aricept TV spots hype benefits, says DDMAC

Aricept TV spots hype benefits, says DDMAC

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Eisai got an FDA untitled letter for two Aricept TV ads that the agency said overstate the efficacy of the drug.

DDMAC letter-writers off to a busy start of 2010

DDMAC letter-writers off to a busy start of 2010

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The FDA's Division of Drug Marketing, Advertising and Communications got off to a busy start in January, issuing nine enforcement letters.

DDMAC cites fishy Cymbalta fibromyalgia ads

DDMAC cites fishy Cymbalta fibromyalgia ads

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The FDA issued an untitled letter upbraiding Lilly for Cymbalta consumer and professional ads.

King's all kid gloves on Embeda launch

King's all kid gloves on Embeda launch

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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.

FDA seeks input on social media regulation

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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.

Sanofi card trick draws warning

Sanofi card trick draws warning

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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.

King warned on Embeda VNRs

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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 lashes Allergan over Latisse website

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DDMAC issued a warning letter to Allergan that singled out misleading aspects of Latisse's brand.com site.

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