USA – FDA expands types of acceptable confirmatory evidence in new guidance
In a new draft guidance, the US Food and Drug Administration (FDA) outlined the types of confirmatory evidence it will accept from sponsors that...
Europe – EMA recommends measures to minimise risk of serious side effects with Janus...
EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat...
USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III
The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified...
USA – Global regulators discuss how they are adapting to AI, real-world data in...
Regulators across the globe have been preparing for the arrival of new artificial intelligence (AI) technologies and advances in real-world data (RWD) they say...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9...
EMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and...
USA – NIH celebrates FDA approval of long-acting injectable drug for HIV prevention
Yesterday the U.S. Food and Drug Administration announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is...
International – ICH guideline M10 on bioanalytical method validation and study sample analysis –...
In response to questions posted to ICH M10 comment period, a number of Questions and Answers have been devised to provide clarity around some...
Europe – EU regulator recommends revoking approval for Novartis’ sickle cell disease drug
The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab).
The...
Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended...
EMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original...
USA – FDA guidance on conducting trials during emergencies shifts away from COVID-19
The US Food and Drug Administration (FDA) issued revised final guidance to assist sponsors, investigators, and institutional review boards conducting clinical trials during disasters...
