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Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
The National Institutes of Health is talking with drugmakers about the potential of scaling up production of an experimental recombinant Ebola vaccine set to enter human testing next month. Read More
The European Medicines Agency is seeking suggestions on promising techniques to identify genomic biomarkers that might spur development of targeted therapies. Read More
Conducting clinical trials with multiple drug candidates from different manufacturers simultaneously will be key to developing new antibacterial therapies, experts seeking to address the growing problem of antibiotic resistance say. Read More
Developers of influenza vaccines in Europe will have to conduct additional postmarket effectiveness studies and expand their criteria for evaluating immune responses of products in the clinical testing phase, according to the European Medicines Agency. Read More
The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More