The European Medicines Agency defines “off-label” the use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration. The majority of marketed medicines world‐wide, including those commonly used or which could...
EMA – New treatment for children with type 2 diabetes
Type 2 diabetes is a chronic disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. It can lead to serious complications if a person does not receive...
Have a look at the EJP RD events and training activities
The European Joint Programme on Rare Diseases (EJPRD) is a Co-fund action aimed to create a comprehensive, sustainable system allowing virtuous circle between research, care and medical innovation. TEDDY Network participates as Partner in this project and all of its...
European Commission launches online public survey on HORIZON EUROPE
The Commission is preparing for the crucial phases of the implementation of Horizon Europe (HE), the next EU research and innovation programme (2021-2027) with a proposed budget of 100 billion. In view of an intensive co-design approach, the Commission has launched an...
TEDDY involvement in the ENCePP activities focused on the EU PAS Register review
The European Union electronic Register of Post-Authorisation Studies (EU PAS Register) is a collection of non-interventional post-authorisation studies (PAS) and was launched in 2010 by ENCePP (European Network of Centres for Pharmacoepidemiology and...
The Italian Medicines Agency AIFA withdraws the paediatric indication for domperidone-containing products
The Italian Medicines Agency AIFA has just released a safety communication about the use of medicines containing domperidone. Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and...
TEDDY is involved in the RESTORE project
We are happy to announce that the TEDDY Network is involved as supporter in RESTORE, a large-scale Research Initiative with the scope to create a consortium aimed to build a coordinated, financially strong, academia-industry partnership in order to tackle the main...
EMA Consultation: ICH guideline E19 on optimisation of safety data collection
EMA has launched a public consultation on the draft ICH Guideline E19 relating to optimization of safety data collection in late-stage pre-approval or post approval studies and promoting selective safety data collection to limit useless burden to study participants...
HMA/EMA TASK FORCE ON BIG DATA
Heads of Medicines Agencies (HMA) – EMA Joint Big Data task force published on 13 February 2019 a summary report on the main outputs and achievements of the task force. In preparing the report, it assessed the generation of “Big data”, their relevant resources and...
FDA Finalises Guidance on Paediatric Information in Drug Labels
The US Food and Drug Administration (FDA) in March released a guidance on the content and placement of paediatric information within the labelling of drugs and biologics products. The guideline provides recommendations to ensure that information on the use of...