Results 21 to 30 of about 80,109 (188)
Frontiers in Medicine, 2020 The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups.
Philip A. Hines +9 more
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The EU Response to the Presence of Nitrosamine Impurities in Medicines
Frontiers in Medicine, 2021 The unexpected detection of nitrosamine impurities in human medicines has recently seen global regulators act to understand the risks of these contaminations to patients and to limit their presence.
Robin Ruepp +7 more
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EUROPEAN MEDICINES AGENCY APPROVED APIXABAN USE IN CARDIOVERSION
, 2015 European Medicines Agency approved apixaban use in ...
core +3 more sources
Frontiers in Medicine, 2021 Since the implementation of the EU Orphan Regulation in 2000, the Committee for Orphan Medicinal Products at the European Medicines Agency has been evaluating the benefits of proposed orphan medicines vs. satisfactory treatment methods.
Maria E. Sheean +24 more
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The Journal of Headache and Pain, 2018 Migraine is a common and burdensome neurological condition which affects mainly female patients during their childbearing years. Valproate has been widely used for the prophylaxis of migraine attacks and is also included in the main European Guidelines ...
Efstratia Vatzaki +5 more
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Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond
Frontiers in Medicine, 2022 Biomarkers are important tools in medicines development and clinical practice. Besides their use in clinical trials, such as for enrichment of patients, monitoring safety or response to treatment, biomarkers are a cornerstone of precision medicine.
Natalie M. Hendrikse +4 more
doaj +1 more source
The European Medicines Evaluation Agency [PDF]
BMJ, 1994 The new agency can be an important catalyst for drug innovation in Europe The European Medicines Evaluation Agency (EMEA) is to be set up in London - a decision that has been wanted and welcomed by the pharmaceutical industry. Many companies are tired of the long delays and the extra work required in submitting applications to 12 or more different ...
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Frontiers in Pharmacology, 2022 Between 2000 and 2021, the European Medicines Agency (EMA) assigned the orphan designation to over 1,900 medicines. Due to their small target populations, leading to challenges regarding clinical trial recruitment, study design and little knowledge on ...
Carla J. Jonker +5 more
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The European Medicines Evaluation Agency [PDF]
BMJ, 1996 Moving towards more transparent drug registration systems The European Medicines Evaluation Agency (EMEA) opened its doors for business just over a year ago and, despite a shaky start, is making progress in implementing the new European drug registration system.
openaire +2 more sources
ESMO Open, 2020 On the 15 November 2018, the Committee for Medicinal Products for Human Use adopted an extension to an existing indication for the use of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with ...
Jorge Camarero +12 more
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