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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
Pharma sponsorship of head-to-head trials comparing two drugs for the same indication may present a serious conflict of interest, a group of American and Italian researchers 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
Sponsors should decrease their use of on-site monitoring in clinical trials in favor of more centralized, risk-based methods that can be largely conducted remotely, an expert says. Read More
Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Bayer Healthcare’s Essure female contraceptive is facing new FDA scrutiny in the wake of a citizen petition alleging data integrity breaches on the part of the manufacturer. 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
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