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Off label use

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

EU’s 10-year paediatric meds report - not bad, but can do better

EU’s 10-year paediatric meds report - not bad, but can do better

label use of adult medicines in children, says the European Commission. ... These include “off-label use of products designed for adults, un-adapted rewards for innovation, and the lack of use of the Orphan Drugs Regulation for paediatric indications”

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  • Healthcare systems

    Healthcare terms - 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. ... A path forward. Real-world evidence is already in use around the world.

  • Does safety sell medicines? Does safety sell medicines?

    New legislation in Europe introduced in 2012 has also led companies to expand what they collect from just side effects to reports of occupational exposure, off-label use and medication errors. ... Through the collection and review of adverse event

  • Pharma deals during February 2013 Pharma deals during February 2013

    Merck &Co has also returned to the biosimilar race following its exit from the Enbrel development programme after Amgen settled an off-label use case for Aranesp in December 2012. ... Between them they will use crowd sourcing to generate novel ideas on

  • Changes to pharmacovigilance legislation in Europe Changes to pharmacovigilance legislation in Europe

    of the marketing authorisation (off-label use), as well as the misuse and abuse of the medicinal product. ... More generally, the competent authority may lay down 'any other conditions or restrictions with regard to the safe and effective use of the

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