Europe – EMA adopts reflection paper on AI/ML in drug development
The European Medicines Agency (EMA) has adopted a reflection paper (RP) on using artificial intelligence (AI) in drug development after considering feedback from scores...
USA – FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults....
Europe – EMA recommends suspension of sickle cell disease medicine Oxbryta
EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as...
USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials
The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance that’s intended to pave the way for using data from research...
USA – FDA’s final guidance on DCTs adds clarity on HCP task log, inspection...
The US Food and Drug Administration’s (FDA) final guidance on decentralized clinical trials (DCTs) addresses some key issues from the draft guidance raised by...
USA – Studies find uneven uptake of biosimilars as availability increases
As biosimilars become increasingly available, they are creating a competitive market with originator products, but uptake of biosimilars among patients is varied and depends...
Europe – Establishing efficacy based on single-arm trials submitted as pivotal evidence in a...
Following a public consultation, the Methodology Working Party (MWP) has finalised the Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation.
The reflection...
USA – FDA drafts guidance on multiregional clinical trials in oncology
In a new draft guidance, the US Food and Drug Administration (FDA) provided recommendations for multiregional clinical trials (MRCTs) in oncology, encouraging sponsors to...
USA – FDA updates guidance on classifying ANDA amendments for GDUFA III
The US Food and Drug Administration (FDA) on Thursday issued updated guidance on the classification of amendments to abbreviated new drug applications (ANDAs) or...
Europe – EMA updates guideline on developing drugs for bipolar disorder
The European Medicines Agency (EMA) on 9 September proposes updating its guideline on developing drugs for treating bipolar disorder (BD) to reflect new medical...
