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Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More
The U.S. FDA’s device center is taking steps to improve the predictability of IDE reviews with the establishment of a new director-level position to oversee the clinical trials in the Office of Device Evaluation, a center official says. Read More
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
New guidance on extrapolating existing data to gain approval for pediatric indications applies to new devices as well as those already approved for adult use, an FDA official says. Read More
CRO Analytics and the Association of Clinical Research Professionals are partnering to develop a more holistic approach to clinical trial site quality. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
Devicemakers that want to ensure enough women participate in their clinical trials should set a clear and prespecified goal and stick to it, experts say. Read More
Sponsors considering whether to use an adaptive clinical trial design should select a number of realistic scenarios and determine how likely each is to succeed with a particular adaptive design, the FDA says. Read More
The FDA is asking clinical investigators who sponsor trials to submit many of the elements that a commercial sponsor would include in an investigational new drug application. Read More
The ayes had it with the House Energy & Commerce Committee May 21, with all 51 members voting to pass the latest version of the 21st Century Cures Act. Read More
The European Medicines Agency Wednesday released final guidance on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More