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off label

This page shows the latest off label news and features for those working in and with pharma, biotech and healthcare.

GSK to reverse ‘no KOLs’ policy, admitting it has hit marketing

GSK to reverse ‘no KOLs’ policy, admitting it has hit marketing

This included a $3bn fine imposed on GSK after it was caught promoting Advair off-label in the US, with a corporate integrity agreement imposed on it by US regulators.

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  • Five questions guiding the way to actual patient-centricity Five questions guiding the way to actual patient-centricity

    We worry about the effort real patients might make, the risks of social media, pharmacovigilance, off-label questions and a minefield of legal requirements.

  • Significant figures Significant figures

    Fast forward to last September and the company’s decision to put ALIS through phase III trials paid off, when it released late-stage results showing 29% of patients with NTM ... or less off-label as it’s not specifically indicated to treat the

  • Healthcare systems

  • The gold standard of scientific evidence The gold standard of scientific evidence

    More than one in five prescriptions in the United States are for an off-label use; providing additional evidence to better understand treatment efficacy and safety is crucial.

  • Creative marketing and compliance Creative marketing and compliance

    Sales people can be using marketing content in good faith, without realising that it is 'off label' and unapproved. ... Get it wrong and not only is there the risk of being 'off brand' (it could even be a matter of life or death), but local regulations

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