Legal/Regulatory

FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer

A treatise on understanding the FDA's latest guidance of low-risk general wellness products.

Five things for pharma marketers to know: Monday, February 9

Five things for pharma marketers to know: Monday, February 9

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Achillion's experimental HCV drug cleared the virus in six weeks when combined with Gilead's Sovaldi; Sanofi will replace a third of its sales managers; GSK shutters Montana vaccine R&D.

Five things for pharma marketers to know: Thursday, February 5

Five things for pharma marketers to know: Thursday, February 5

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FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.

Five things for pharma marketers to know: Tuesday, February 3

Five things for pharma marketers to know: Tuesday, February 3

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President Barack Obama states in budget proposal that government should negotiate drug pricing; J&J's rare cancer drug's review is expedited; inhalable insulin hits pharmacy shelves.

Five things for pharma marketers to know: Thursday, January 22

Five things for pharma marketers to know: Thursday, January 22

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Takeda COO Weber refuses Sanofi CEO post; J&J seeks $7.2 billion from Boston Scientific over 10-year old-Guidant acquisition; UCB submits epilepsy drug for US and EU approval.

Five things for pharma marketers to know: Wednesday, January 21

Five things for pharma marketers to know: Wednesday, January 21

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President Barack Obama says personalized medicines need financial support in SOTU Address; Salix explores M&A options; lobbying groups PhRMA and BIO say generic painkillers without abuse-deterrent features should be pulled from shelves.

Five things for pharma marketers to know: Friday, January 16

Five things for pharma marketers to know: Friday, January 16

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CMS head Marilyn Tavenner has resigned; Depomed acquires Nucynta pain pill from J&J; Merck's innovation lead leaves for insurer.

Five things for pharma marketers to know: Wednesday, January 14

Five things for pharma marketers to know: Wednesday, January 14

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Pharma ad budgets are growing, says IPG; Medical device tax debate rages on; Pfizer has PCSK9 pill in the works.

OPDP slams print ad in Untitled Letter

OPDP slams print ad in Untitled Letter

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The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."

 

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