USA – FDA expands bivalent COVID boosters to kids as young as 5
The US Food and Drug Administration (FDA) has updated the emergency use authorizations (EUA) for the bivalent Pfizer-BioNTech and Moderna COVID-19 boosters to expand...
International – ICH advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...
Europe – Data Quality Framework for EU medicines regulation
As acknowledged in the recommendations of the HMA-EMA Joint Big Data Task Force (BDTF) and the workplan of the HMA-EMA Joint Big Data Steering...
International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...
France – Monkeypox : la HAS complète ses recommandations sur la vaccination
Pour faire face à l’épidémie de Monkeypox, la HAS avait recommandé le 8 juillet dernier une vaccination préventive pour les groupes les plus exposés au...
France – La HAS publie le référentiel de certification des logiciels d’aide à la...
La Haute autorité de santé (HAS) a publié le 29 septembre le référentiel de certification par essai de type des logiciels d'aide à la...
USA – Experts call for federal incentives to promote clinical trial diversity
A combination of federal incentives and regulations, similar to the approach used to increase pediatric drug development, is needed to increase the diversity of...
Europe – High-quality data to empower data-driven medicines regulation in the European Union
EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the...
International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing...
France – Le logiciel officinal Pharmony One obtient l’agrément Sesam-Vitale
Pharmony One, solution de gestion d'officine en mode SaaS (software as a service, logiciel en tant que service) a décroché l'agrément Sesam-Vitale Addendum 8,...
