Jun 15, 2021 | News, Regulatory
The European Medicines Agency (EMA) has added another blood condition side effect to the growing list for AstraZeneca’s COVID-19 vaccine. The rare blood condition known as capillary leak syndrome causes blood to spill from blood vessels to nearby muscles and...
Jun 10, 2021 | News, Regulatory
Following the European Medicines Agency (EMA) and the European Commission and Heads of Medicines Agencies’ (HMA) release of principles outlining a standardized approach to electronic product information (ePI) last year, the EMA is holding a stakeholder consultation to...
Jun 2, 2021 | News, Regulatory
Israel’s Ministry of Health has found a possible link between myocarditis (heart inflammation) in males aged 16-30 and the second Pfizer vaccine. In examining the matter, the Ministry has disclosed the findings of its commissioned study stating that among the total 5...
May 3, 2021 | Classification System, e-Labeling, EMA, Health, Medical Translation, Quality, Regulatory
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
Apr 5, 2021 | News, Regulatory
The European Commission has granted Orphan Designation for PBKR03, a treatment from Passage Bio to treat Krabbe disease. Krabbe disease is a rare lysosomal storage disorder that currently does not have any approved disease-modifying treatments. The approval comes...
