EMA publishes list of contact details for pharmacovigilance enquiries
The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.
The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.
There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.