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Clinical trial sponsors are increasingly looking to optimized trial design methods to simplify their studies and increase efficiency, but obstacles still stand in the way, an expert says. Read More
An article published in last month’s Journal of the American Medical Association is casting doubt on the idea that the scientific community and the general public should trust clinical trial results. Read More
Sponsors of novel drug therapies can evaluate their candidates against competing products in the UK without the threat of litigation, thanks to amended patent law that took effect Oct. 2. Read More
Sponsors say an FDA plan to require informed consent documents to include detailed descriptions of treatment alternatives to experimental drugs could confuse patients such that recruiting clinical trial subjects will be nearly impossible, drugmakers argue. Read More
Indian authorities are reminding clinical investigators that trial applications must include information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product and existing options. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
Clinical trial sponsor Brava was hit with an FDA warning letter over several informed consent violations and conflict-of-interest issues related to evaluations of its fat micro grafting device. Read More
Sponsors submitting plans to test drug products in children in Europe need to provide the European Medicines Agency with information on all formulations being developed, according to final guidance published Sept. 27. Read More
Companies developing pediatric vaccines for diphtheria, tetanus and pertussis, or DTaP, can streamline the process by using a single dosing schedule in clinical trials, new guidance from the European Medicines Agency says. Read More
Starting Jan. 1, drugmakers that sell products in the EU will have to make publicly available clinical trial data used to support marketing authorization. Read More
Local and regional medicines authorities need to have mechanisms in place to ensure that clinical trial data quality is preserved in secondary studies, a Washington, D.C.-based think tank says. Read More