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FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer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.

Device maker pays feds $2.8M over physician false claims

Device maker pays feds $2.8M over physician false claims

Medtronic, as part of the settlement, will pay $602,000 to a whistleblower to settle charges it caused physicians to submit false claims to federal health programs.

Obama gives details on Precision Medicine Initiative

Obama gives details on Precision Medicine Initiative

President Barack Obama's recently unveiled Precision Medicine Initiative hopes to develop a new model of patient-driven research with the promise of accelerating biomedical discoveries and provide clinicians with new tools, knowledge, and therapies.

FDA updates DTC ad policy on risk information

FDA updates DTC ad policy on risk information

FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect "recent social science research."

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

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

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

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

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

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

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

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

 

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