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

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FDA: Kicking off the PDUFA VI Reauthorization Process
FDA approves Repatha to treat certain patients with high cholesterol
FDA takes action against three tobacco manufacturers for making “additive-free” and/or “natural” claims on cigarette labeling
FDA Guideline for Industry: Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile
AEMPS: Información a los Laboratorios Titulares de Medicamentos de Uso Humano que contienen “adrenalina” para su administración mediante autoinyectores. Decisión de la Comisión C(2015) 5886 final, de fecha 14.8.2015
FDA extends use of Promacta in young children with rare blood disorder
FDA Guidance For Industry: Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines
FDA Drug Safety Communication: Picato (ingenol mebutate) Gel – FDA Warns of Severe Adverse Events, Requires Label Changes
EMA: Updated guidance on good clinical practice released for consultation
Infarmed: Sistema de Preços de Referência – Aditamento de novos grupos homogéneos