Viglya wishes to establish transparent and open communication with its stakeholders. This section offers new and updated information regarding the company and the life science sector.
EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and [...]
Na sequência de diversas notícias relativas à utilização de medicamentos contendo metamizol, o Infarmed informa: O metamizol é um medicamento utilizado para o tratamento da dor e febre há cerca de 40 anos. Em Portugal, [...]
FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell [...]
A la suite des résultats d’une enquête française de pharmacovigilance sur les préparations coliques, l’ANSM souhaite rappeler les risques liés à leur utilisation. Des troubles hydro-électrolytiques survenant parfois dans un contexte de mésusage peuvent être [...]
The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. This guidance focuses on development of two-drug combinations of previously approved drugs, although the general approach [...]
This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines [...]