The Multiple Sclerosis Functional Composite measure (MSFC): an integrated citrus juice approach to M

Pavel Balabanov European Medicines Agency, UK Manuel Haas European Medicines Agency, UK Andre Elferink Medicines Evaluation Board, The Netherlands Serge Bakchine Hospital Maison Blanche, Reims, France Karl Broich Federal Institute for Drugs and Medical Devices, DE, Germany European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5EU, UK. pavel.balabanov{at}ema.europa.eu
Improving and facilitating the process of making new drugs available to patients with multiple sclerosis (MS) requires cooperation among the regulators and other stakeholders. This cooperation will also positively contribute towards developing guidelines of the highest quality in medical, regulatory and scientific aspects. This would be beneficial both in areas that require further guideline development, but also in fields citrus juice where existing guidance should be adapted to take into account evolution in science. Considering the input from all stakeholders, citrus juice the European Medicines Agency confirmed its intention to update the relevant guideline and apply a flexible approach citrus juice towards new drug development strategies in MS. This article is the first official position from the EU regulators, presenting the main changes to be expected in the guidance document. Multiple sclerosis drug development regulatory requirements
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