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Latest News | 7 June 2013

Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer

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Earlier this week, the US Food and Drug Administration (FDA) made a quiet but important announcement: Supplies of the drug Doxirubicin Liposomal Injection, a widely used cancer drug that has been Read More...


Latest News | 5 June 2013

Unfair Balance and Unsubstantiated Claims Prompt Untitled Letter to Pharmaceutical Manufacturer

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An Untitled Letter sent by the US Food and Drug Administration (FDA) in May 2013 calls out Sigma-tau Pharmaceuticals for allegedly marketing its chemotherapy drug Oncaspar (pegaspargase) using a Read More...


Regulatory Update | 3 June 2013

Changes Coming to Australian Advertising Rules

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Australia’s Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The Read More...


Latest News | 31 May 2013

FDA Looks to Big Data to Assist Off-Label Marketing Investigations

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The US pharmaceutical industry has long been known to aggressively market its products, and not always in a scrupulous fashion. Now a new notice posted on the Federal Business Opportunities (FBO) Read More...


Latest News | 19 February 2013

Could the Claim of 'Crazyballs' Constitute a Promotional Claim and Violate Federal Law?

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The patient is male, middle-aged and has just suffered a massive heart attack. For now, he’s sedated, covered by blue cloth and being operated on by a female surgeon, with another attending surgeon Read More...


Latest News | 30 January 2013

Rare Multi-Agency Warning Letter Slams Flu Product

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The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus.The letter, sent on Read More...


Latest News | 4 December 2012

In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech

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In a potentially landmark ruling, the US 2nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain Read More...


Latest News | 23 October 2012

FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

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The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc. after regulators said an inspection found deficiencies Read More...


Latest News | 17 October 2012

Under Fire, Abbott Suspends Marketing Program in India

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Officials with Abbott Laboratories have announced the suspension of a controversial policy that has stoked controversy with critics who claim the company is buying favors from prescribing physicians Read More...


Latest News | 16 October 2012

Crackdown on Cosmetic Marketing Claims Expands as Avon Sent Warning Letter

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The US Food and Drug Administration (FDA) has taken aim at another of the cosmetic industry's giants over the use of marketing claims reserved for approved pharmaceutical products—its fourth warning Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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