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AEMPS: Solicitudes de autorización de comercialización de medicamentos de uso humano. Monográfico de bases legales

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ANSM: Modification de la durée maximale de prescription des spécialités Méthadone AP-HP, gélule
FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic
ANSM: Newsletter nº 12 Septembre 2014
ANSM: SonoVue® (hexafluorure de soufre) – Modification des contre-indications, mises en garde et précautions d’emploi chez les patients avec une pathologie cardiovasculaire instable
FDA approves Ofev to treat idiopathic pulmonary fibrosis
FDA – CDER SBIA Update: New Guidance Documents
FDA approves Esbriet to treat idiopathic pulmonary fibrosis
UK MHRA: EMA public consultation on functional specification for portal and database that will underpin the EU Clinical Trials Regulation (deadline 31 October 2014)
AEMPS – Corrección de la nota informativa: Ácido valproico: nuevas recomendaciones de uso en niñas y mujeres con capacidad de gestación
EMA: Concept paper on the need for revision of the points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome