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Latest News | 14 March 2013

Untitled Letter Claims Brochure Misrepresents Bladder Cancer Detection Dye

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A new untitled letter sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) claims that a brochure for Photocure ASA's bladder cancer detection solution Read More...


Latest News | 28 February 2013

Company's 'Game-Changing' Claim Needs More Game, FDA Says

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The US Food and Drug Administration (FDA) has sent an untitled letter to ParaPRO, a start-up pharmaceutical company whose products focus on the treatment of head lice, saying the company's Read More...


Latest News | 22 February 2013

FDA Warning to Alcon Laboratories Fourth Since 2006 Regarding Similar Allegations

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Ophthalmic products manufacturer Alcon Research has been hit with an untitled letter by the US Food and Drug Administration (FDA) regarding its Pataday allergy eye drops, which regulators claim were Read More...


Latest News | 14 February 2013

Untitled Letter Targets Unapproved HIV Testing Device Posing as Approved Product

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A new untitled letter sent by US regulators to an Internet domain hosting company alleges that the company marketed an unapproved diagnostic test capable of testing for HIV, thereby violating federal Read More...


Latest News | 15 October 2012

FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims

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The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Genentech over marketing materials used to promote its drug Tarceva Read More...


Latest News | 2 October 2012

Endo Pharmaceuticals Hit With Untitled Warning Letter for Marketing Brochure

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An untitled letter sent to manufacturer Endo Pharmaceuticals by the US Food and Drug Administration (FDA) accuses the company of promoting Vantas, a subcutaneous implant used as a palliative treatment Read More...


Latest News | 24 July 2012

Untitled Letter Cites Company for Risk Omissions, Insufficient Trial Strength

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The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion(OPDP) has sent an untitled letter to New Jersey-based Validus Pharmaceuticals for alleged deficiencies related to a Read More...


Latest News | 18 July 2012

Untitled Letter Cites BMS for Alleged Misbranding

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Pharmaceutical manufacturer Britsol-Myers Squibb was the recipient of an Untitled Letter from the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) regarding Read More...


Latest News | 9 July 2012

Untitled Letter to Acorda Therapeutics Highlights Recent FDA Review Trends

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The US Food and Drug Administration (FDA) sent two untitled warning letters to pharmaceutical companies in as many days in June, warning two companies regarding alleged infractions contained within Read More...


Latest News | 6 July 2012

Valeant, Lundbeck Warned for Leaving Warnings out of Promotional Video

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US regulators have sent pharmaceutical manufacturer Valeant Pharmaceuticals an untitled letter after finding a promotion for its Huntington’s disease-treatment drug Xenazine omits “material facts,” Read More...


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