Draft ICH M13A guideline on bioequivalence open for consultation
By Giuliana Miglierini The draft ICH M13A harmonised guideline “Bioequivalence for immediate-release solid oral dosage forms” was endorsed…
ACT EU’s Workplan 2022-2026
by Giuliana Miglierini The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched…
Steps forward towards the new framework for HTA
By Giuliana Miglierini The long-waited European regulation on Health Technology Assessment (HTA) was adopted by the Council of…