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The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing(More)
441 research activities have been under way within the pharmaceutical and biotech industry to qualify biomarkers, but that many of the data generated by these activities remain within the firewalls of individual companies. These data are shared neither among companies nor with regulatory agencies. In this article, we describe the efforts of the various(More)
The evaluation of quality, safety and efficacy of medicinal products by regulatory agencies is a necessary step for obtaining marketing authorisation in the European Union (EU). The objective of this paper is to outline some key aspects of the EU regulatory system relevant to the field of oncology. Regulatory standards in oncology and the experience with(More)
Pharmacogenetics, one of the cornerstones of personalized medicine, has the potential to change the way in which health care is offered by stratifying patients into various pretreatment categories, such as likely responders, likely non-responders or likely to experience adverse drug reactions. In order to advance drug development and regulatory science,(More)
Unmet medical needs are a priority for organizations such as the WHO and major public-private initiatives, such as Innovative Medicines Initiative, were established to speed up the development of better and safer medicines for patients. To assist such projects, the EMA in its 'Road Map to 2015' considered the mapping of unmet medical needs as a priority.(More)
Pharmacogenomics, the study of variations of DNA and RNA characteristics as related to drug response, has become an integral part of drug development and pharmacovigilance, as reflected by the incorporation of pharmacogenomic data in EU product information. In this short review article, we describe recent European Medicines Agency initiatives intended to(More)
507 gests that many applications lack this kind of comprehensive and prospective approach. In fact, European regulators wish to maintain flexibility of their guidance and welcome novel approaches in this rapidly progressing field. Biologicals have to be seen as individuals. Thus, there is hardly an ideal fit-to-purpose recipe for immunogenicity evaluation.(More)
This article provides an overview of the European Union (EU) framework for the marketing authorisation of medicinal products, at both European and National level, and aims to demonstrate the current position and experience with nanomedicines. It will be described how the EU promotes the development of new nanomedicines by publishing guidance, providing(More)