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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
The European Medicines Agency has approved a controversial policy that grants researchers access to detailed clinical trial data submitted in support of drug approvals. Read More
The FDA is considering letting branded drugmakers reserve a proprietary name for a new product, with the goal of avoiding potential delays by approving permanent drug names well in advance of product launch. Read More