Annagrazia ALTAVILLA, Chair of TEDDY, has been appointed as consultant/expert of the Council of Europe - Bioethics Division, within the new DH -BIO Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020-2025). This plan provides specific...
Public consultation on European Medicines Agencies Network Strategy to 2025
The European medicines regulatory network (EMRN) represents a unique response to the challenge of regulating human and veterinary medicines across a diverse group of countries. It includes the national competent authorities (NCAs) of the 27 EU Member States plus those...
Good Lay Summary Practice: TEDDY answered to the Public Consultation
The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. However, there is no guidance for all types of sponsors on how best to handle the development...
TEDDY comments to EMA Discussion Paper: Secondary Use of Data for Medicines and Public Health Purposes
The European Medicines Agency (EMA) is preparing the guidance on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines. TEDDY Network provided its contribution to the...
Enpr-EMA comment to FDA docket on Rare Disease Clinical Trial Networks submitted
The Food and Drug Administration launched a docket to require inputs and comments from patients, patient advocates, the scientific community, health professionals, regulatory and health authorities and general public regarding practical steps to establish a rare...
EMA approved a new treatment for children with chronic kidney disease
EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. Patients with severe...
FDA approved First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their...
EMA published the Guideline on registry-based studies. Launch of Public Consultation
EMA has published the draft Guideline on registry-based studies for a three-month public consultation. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence. Studies based on patient registries generate real-world...
The Lancet 2020 Campaign on child and adolescent health
The world’s leading independent general medical journal the Lancet started “The Lancet 2020 Campaign on child and adolescent health” with the aim to reiterate the centrality of child survival and wellbeing in global development. Several initiatives have been proposed...
Brexit: which will be the changes in regulatory procedures and guidelines in paediatrics?
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. The European Medicines Agency (EMA) has made...