The EMA has published important guidance on the clinical development of new gout treatments

The finalised guidelines show the European Medicines Agency’s (EMA) expectations of manufacturers involved in the clinical development of new urate-lowering therapies (ULTs) and anti-inflammatory treatments of gout. Read more “The EMA has published important guidance on the clinical development of new gout treatments”

The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals

An article published in Clinical Pharmacology & Therapeutics by the European Medicines Agency (EMA), describes the interactions needed between stakeholders to accelerate patient access to ground-breaking new therapies. Read more “The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals”

Did you know that the Enpr-EMA has published a draft framework regarding paediatric clinical trial preparedness?

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has invited relevant stakeholders, and anyone involved in the preparation and conduct of paediatric clinical trials, to send comments on the draft framework released about paediatric clinical trial preparedness. Read more “Did you know that the Enpr-EMA has published a draft framework regarding paediatric clinical trial preparedness?”