International – WHO seeks to align biowaiver policy with ICH guidelines
The World Health Organization (WHO) wants to align its bioequivalence classifications with other global guidelines by reducing the number of in vivo studies required to prove...
International – ICH paper calls for ‘stepwise’ harmonization of RWE
The International Council for Harmonisation (ICH) issued a Reflection Paper outlining a “stepwise” approach to harmonization of real-world data and evidence (RWD/RWE) that includes...
International – ICH charts new topics, touts progress in updating existing guidelines
The International Council for Harmonisation (ICH) announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for...
International – Genetically altered vaccines developed to help eradicate polio
Polio is a highly infectious viral disease that largely affects children aged under five years. The virus is transmitted by person-to-person and multiplies in...
