USA – FDA offers details on PDUFA VII STAR review pilot
The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten...
International – ICH Q14: Pharma groups want clarity on benefits of enhanced approach
Pharmaceutical industry groups questioned whether following the enhanced approach in International Council for Harmonization (ICH) Q14 guidance will confer regulatory relief for manufacturers that...
USA – FDA warns that emerging Omicron subvariant could make Evusheld obsolete
AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each...
France – Avis relatif à la couverture des besoins de la population générale en...
Le HCSP évalue la couverture des besoins nutritionnels de la population pour le fer et la vitamine D dans le cadre de la mise...
France – L’ANSM publie les nouvelles règles des bonnes pratiques de préparation
Les nouvelles règles ont été élaborées grâce à un Comité scientifique regroupant pharmaciens hospitaliers, officinaux, inspecteurs et universitaires, ainsi qu’à partir des propositions formulées...
France – Virus de la variole du singe : recommandations pour sécuriser les dons...
Ces recommandations sont détaillées dans une note publiée sur notre site internet, mise à jour en novembre 2016. Elles concernent la collecte de selles pour la...
USA – OIG raises concerns about accelerated approval pathway
More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years...
UK – European Commission Decision Reliance Procedure (EC DRP) extension
European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure British people...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
International – WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out
Emphasising that the global pandemic is ‘not over’, the ACT-Accelerator’s Council Tracking and Accelerating Progress Working Group – co-chaired by Indonesia and the US...
