EU Pharma Alarmed By Regional Variations In ICH's Draft Biowaiver Guideline
European drug companies have expressed concern over region-specific requirements variations permitted in an ICH guideline that proposes a harmonized approach to granting waivers for in vivo bioequivalence studies.
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M9 Biowaivers Guidance Nearly Harmonised During ICH Meeting
Experts came close to harmonizing draft ICH M9 guidance on biowaivers, which allow in-vitro in lieu of in-vivo bioequivalence testing under certain circumstances. Final guidance is expected soon, Drug Information Association annual meeting told.
EU Multistakeholder Project Aims To Give eConsent The ‘Place It Deserves’
The EU Forum for Good Clinical Practice is working on boosting the use of electronic informed consent, the uptake of which in clinical trials has been poor.
Global Medtech Guidance Tracker: May 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.