Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in the SmPC and PIL.GxP News
European Pharmacopoeia Commission Adopts First General Texts on mRNA Vaccines
EMA Guideline on Quality, non-clinical and clinical Requirements for Investigational Medicinal Products for Advanced Therapies in Clinical Trials
EU Map to Clinical Trials
EMA Concept Paper on Model Informed Drug Development
FDA Warning Letter: Unlicensed biological Product, Misbranding and many other Offences
Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14
12th Edition of The International Pharmacopoeia
Inadequate Dissolution Testing and Process Validation Trigger FDA Warning Letter
European Pharmacopoeia Commission Adopts First General Texts on mRNA Vaccines
Development of a Risk-based Quality System for CMC R&D Laboratories in Drug Development
