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Clinical trial sites should determine their compatibility with central institutional review boards, including whether software they use to interface with the local IRB is capable of handling an outside review board, an expert says. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
While China’s year-old medical device regulations require clinical trials for Class II and Class III devices, there are some exceptions and regulators are in the process of finalizing guidance to help companies take advantage of them, an expert says Read More
The FDA is advising devicemakers that plan to support a premarket submission with data from clinical studies conducted outside the U.S. to meet with the agency before finalizing their trial designs. Read More
A new interactive clinical data platform for Apple devices is capable of not only boosting participation in data-driven disease studies, but also collecting clinical data more easily, the tech giant says. Read More
The FDA saw an 11 percent increase in inspections carried out as part of a sweeping program to improve inspectors’ understanding of clinical practices during fiscal year 2014. Read More
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
While overall survival remains the desired endpoint in treating non-small cell lung cancer, progression-free survival may suffice as the primary endpoint, the FDA says. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
Canadian biotech company Tekmira will restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, following the FDA’s downgrading of a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More