USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
Europe – EMA Management Board: highlights of October 2023 meeting
EMA’s Management Board met on 5 October in Amsterdam.
Clinical trials in the EU
The Board adopted revised transparency rules for the publication of information on clinical...
International – ICH adopts Q13 guideline on continuous manufacturing
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing....
UK – Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis
The new guidance specifically applies to patients with a Psoriasis Area and Severity Index score of ten or more, a Dermatology Life Quality Index...
USA – Prenatal cannabis exposure associated with mental disorders in children that persist into...
Prenatal cannabis exposure following the middle of the first trimester—generally after five to six weeks of fetal development—is associated with attention, social, and behavioral...
International – ICH targets cell and gene therapies, real-world data as topics ripe for...
Officials from Health Canada and the pharmaceutical industry addressed plans to develop harmonized guidelines on cell and gene therapies and on the design of...
International – ICH E11A: Pharma groups want more information on data extrapolation, pediatric biomarkers
Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug...
